Manufacturer's By Device Bone-screw internal spinal fixation system non-sterile-Bone-screw internal spinal fixation system non-sterile

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Manufacturer Address Authorised Representative Address Date Registered MHRA Reference Number
Aesculap AGAm Aesculap Platz

Tuttlingen
78532

Germany
B. Braun Medical LtdBrookdale Road Chapeltown

Sheffield
South Yorkshire S35 2PW

United Kingdom
03/28/202112983
ARTFX MEDICAL LLC50 Laura St N 25th floor #2524

JACKSONVILLE
FL 32202

United States
CMC Medical Devices LTDOffice 32 19-21 Crawford Street

London
W1H 1PJ

United Kingdom
08/05/202217973
Beijing Libeier Bio-engineering Institute Co. Ltd12 Chuangxin Road Changping Science and Technology Park
Changping Area
Beijing
102299

China
JRI Orthopaedics Ltd18 Churchill Way JRI Orthopaedics ltd

Sheffield
s35 2py

United Kingdom
11/15/202226917
Biedermann Motech GmbH & Co. KGBertha-von-Suttner Straße 23

Villingen-Schwenningen
Baden-Württemberg 78054

Germany
Biedermann Motech International Ltd.4 Wharfe Mews Cliffe Terrace

Wetherby
LS22 6LX

England United Kingdom
05/09/202215436
Biedermann Motech GmbH & Co. KGBertha-von-Suttner Straße 23

Villingen-Schwenningen
Baden-Württemberg 78054

Germany
Biedermann Motech International Ltd.4 Wharfe Mews Cliffe Terrace

Wetherby
LS22 6LX

England United Kingdom
05/09/202215436
Biomet Trauma56 East Bell Drive

Warsaw
Indiana 46582

United States
Zimmer Biomet UK LimitedStella Building Windmill Hill Business Park
Whitehill Way
Swindon
SN5 6NX

England United Kingdom
04/26/202113878
Changzhou Wujin Jinxingda Medical Appliance Co. Ltd.Wujin Weave Industrial Park Hutang Town
Wujin District
Jiangsu
Changzhou 213162

China
Medimap Ltd2 The Drift

Thurston
Suffolk IP31 3RT

United Kingdom
04/15/202221910
Covision Medical Technologies Ltd.Lawn Rd. Carlton In Lindrick

Worksop
S819LB

United Kingdom





01/06/20209465
Depuy Spine Inc.325 Paramount Drive
Paramount Dr Raynham
Bristol
MA 02767

United States
Johnson & Johnson Medical LtdBaird House 4 Lower Gilmore Bank

Edinburgh
EH3 9QP

Scotland United Kingdom
06/22/202115419
Depuy Spine Inc.325 Paramount Drive
Paramount Dr Raynham
Bristol
MA 02767

United States
Johnson & Johnson Medical LtdBaird House 4 Lower Gilmore Bank

Edinburgh
EH3 9QP

Scotland United Kingdom
06/22/202115419
EUROS SASZ.E. Athélia III

La Ciotat
13600

France
Lindare Medical LtdSummerfield Romden Road

Smarden
Kent TN27 8QZ

England United Kingdom
07/04/202225186
HumanTech Spine GmbHGewerbestrasse 5

Steinenbronn
71144

Germany
Osteon Medical Ltd133 Tame Road Birmingham

Birmingham
B67DG

England United Kingdom
02/08/202322714
K2M Group Holdings Inc600 Hope Parkway SE

Leesburg
Virginia 20175

United States
Stryker UK LtdStryker House Hambridge Road

Newbury
Berkshire RG14 5AW

England United Kingdom
03/18/202112740
K2M Group Holdings Inc600 Hope Parkway SE

Leesburg
Virginia 20175

United States
Stryker UK LtdStryker House Hambridge Road

Newbury
Berkshire RG14 5AW

England United Kingdom
03/18/202112740
Medicon eGMedicon eG Gansacker 15
78532 Tuttlingen
Tuttlingen
78532

Germany
QARA Business Solutions LtdCoverdale House 10 Purshall Close
Redditch
Redditch
Worcestershire B974PD

United Kingdom
07/16/202115978
Medicon eGMedicon eG Gansacker 15
78532 Tuttlingen
Tuttlingen
78532

Germany
QARA Business Solutions LtdCoverdale House 10 Purshall Close
Redditch
Redditch
Worcestershire B974PD

United Kingdom
07/16/202115978
Medicrea International5389 Route de Strasbourg Vanica

Rillieux-La-Pape
69140

France
Medtronic LimitedBuilding 9 Croxley Park

Watford
Herts WD18 8WW

England United Kingdom
11/08/202119556
Medicrea International5389 Route de Strasbourg Vanica

Rillieux-La-Pape
69140

France
Medtronic LimitedBuilding 9 Croxley Park

Watford
Herts WD18 8WW

England United Kingdom
11/08/202119556
MEDOS INTERNATIONAL SARLCHEMIN-BLANC 38

LE LOCLE
2400

Switzerland
Johnson & Johnson Medical LtdBaird House 4 Lower Gilmore Bank

Edinburgh
EH3 9QP

Scotland United Kingdom
04/21/202113645
MEDOS INTERNATIONAL SARLCHEMIN-BLANC 38

LE LOCLE
2400

Switzerland
Johnson & Johnson Medical LtdBaird House 4 Lower Gilmore Bank

Edinburgh
EH3 9QP

Scotland United Kingdom
04/21/202113645
MEDOS INTERNATIONAL SARLCHEMIN-BLANC 38

LE LOCLE
2400

Switzerland
Johnson & Johnson Medical LtdBaird House 4 Lower Gilmore Bank

Edinburgh
EH3 9QP

Scotland United Kingdom
04/21/202113645
Medtronic Sofamor Danek Inc.1800 Pyramid Place

Memphis
TN TN 38132

United States
Medtronic LimitedBuilding 9 Croxley Park

Watford
Herts WD18 8WW

England United Kingdom
03/09/202112579
Medtronic Sofamor Danek Inc.1800 Pyramid Place

Memphis
TN TN 38132

United States
Medtronic LimitedBuilding 9 Croxley Park

Watford
Herts WD18 8WW

England United Kingdom
03/09/202112579
Medtronic Sofamor Danek Inc.1800 Pyramid Place

Memphis
TN TN 38132

United States
Medtronic LimitedBuilding 9 Croxley Park

Watford
Herts WD18 8WW

England United Kingdom
03/09/202112579
Medtronic Sofamor Danek Inc.1800 Pyramid Place

Memphis
TN TN 38132

United States
Medtronic LimitedBuilding 9 Croxley Park

Watford
Herts WD18 8WW

England United Kingdom
03/09/202112579
Norm Tibbi Urunler Ithalat Ihracat San. ve. Tic. Ltd. StiIvedik O.S.B. 1468 Cad. No:193

Yenimahalle/Ankara
06378

Turkey
Edge Medical Ltd500 Styal Road

Manchester
M22 5HQ

England United Kingdom
05/17/202328687
NuVasive Inc.7475 Lusk Blvd San Diego CA 92121 United States

San Diego
92121

United States
NuVasive UK LimitedSuite B Ground Floor Caspian House The Waterfront Elstree

London
Hertfordshire WD63BS

England United Kingdom
04/25/202212293
Orthofix Inc.3451 Plano Parkway

Lewisville
Texas 75056

United States
Emergo Consulting (UK) Limited Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ

England United Kingdom
11/07/202118982
Orthofix Inc.3451 Plano Parkway

Lewisville
Texas 75056

United States
Emergo Consulting (UK) Limited Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ

England United Kingdom
11/07/202118982
Orthofix Inc.3451 Plano Parkway

Lewisville
Texas 75056

United States
Emergo Consulting (UK) Limited Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ

England United Kingdom
11/07/202118982
Orthofix Ltd.6 Waltham Park Waltham Road
White Waltham
Maidenhead
Berkshire SL6 3TN

England United Kingdom





11/22/202120294
Orthofix Ltd.6 Waltham Park Waltham Road
White Waltham
Maidenhead
Berkshire SL6 3TN

England United Kingdom





11/22/202120294
Pioneer Surgical Technologies Inc.375 River Park Circle

Marquette
Michigan 49855

United States
Qarad UK Ltd.8 Northumberland Ave

Westminster
London WC2N 5BY

England United Kingdom
04/29/202114167
Shanghai Sanyou Medical Co. Ltd.385 Huirong Road Jiading District

Shanghai
201815

China
Wellkang LtdEnterprise Hub NW Business Complex 1 Beraghmore Road

Derry Northern Ireland
BT48 8SE

Northern Ireland United Kingdom
12/01/202227153
SIGNUS Medizintechnick GmbHIndustriestr. 2

Alzenau
63755

Germany
Emergo Consulting (UK) Limited Compass House Vision Park Histon c/o Cr360 – UL International

Cambridge
CB24 9BZ

England United Kingdom
04/30/202114340
Stryker Spine a division of Stryker Corporation2 Pearl Court

Allendale
New Jersey 07401

United States
Stryker UK LtdStryker House Hambridge Road

Newbury
Berkshire RG14 5AW

England United Kingdom
03/03/202112473
Stryker Spine a division of Stryker Corporation2 Pearl Court

Allendale
New Jersey 07401

United States
Stryker UK LtdStryker House Hambridge Road

Newbury
Berkshire RG14 5AW

England United Kingdom
03/03/202112473
Stryker Spine a division of Stryker Corporation2 Pearl Court

Allendale
New Jersey 07401

United States
Stryker UK LtdStryker House Hambridge Road

Newbury
Berkshire RG14 5AW

England United Kingdom
03/03/202112473
SUZHOU AND SCIENCE & TECHNOLOGY DEVELOPMENT CORP.NO.2 An Sheng Road He Xing Jin Feng Town Zhang Jia Gang City

Jiangsu Province
215625

China
SUNGO Certification Company Limited3rd Floor 70 Gracechurch Street

London
EC3V 0HR

England United Kingdom
08/17/202225521
SYNTHES GMBHEIMATTSTRASSE 3

4436 OBERDORF
n/a

Switzerland
Johnson & Johnson Medical LtdBaird House 4 Lower Gilmore Bank

Edinburgh
EH3 9QP

Scotland United Kingdom
02/21/202112260
SYNTHES GMBHEIMATTSTRASSE 3

4436 OBERDORF
n/a

Switzerland
Johnson & Johnson Medical LtdBaird House 4 Lower Gilmore Bank

Edinburgh
EH3 9QP

Scotland United Kingdom
02/21/202112260
S.M.A.I.O2 Place Berthe Morisot Parc Technologique

SAINT-PRIEST
69800

France
Orthomotion Medical LtdUnit 1 Area A Creamery Industrial Estate Kenlis Road
Barnacre
Preston
Lancashire PR3 1GD

England United Kingdom
05/29/202214855
S.M.A.I.O2 Place Berthe Morisot Parc Technologique

SAINT-PRIEST
69800

France
Orthomotion Medical LtdUnit 1 Area A Creamery Industrial Estate Kenlis Road
Barnacre
Preston
Lancashire PR3 1GD

England United Kingdom
05/29/202214855
ulrich GmbH & Co.KGBuchbrunnenweg 12

Ulm
89081

Germany
Qserve Group UK Ltd. 49 Greek Street

London
W1D 4EG

England United Kingdom
04/15/202213424
ZimmerBiomet Spine Inc10225 Westmoor Drive

Colorado
Westminster 80021

United States
Biomet 3i UK Ltd1 Glass Wharf Burges Salmon Rep Office

Bristol
BS2 0ZX

England United Kingdom
11/09/202226882
ZimmerBiomet Spine Inc10225 Westmoor Drive

Colorado
Westminster 80021

United States
Biomet 3i UK Ltd1 Glass Wharf Burges Salmon Rep Office

Bristol
BS2 0ZX

England United Kingdom
11/09/202226882