Manufacturer's Devices - Osteonic Co. Ltd

Address:




303Ho 405Ho 505-2Ho 505-3Ho 902Ho 1004Ho 1005Ho 1201Ho 1202Ho 1206Ho 38

Digital-ro 29-gil Guro-gu

Seoul

08381

South Korea


Authorised Representative/ UK Responsible Person
Name: Emergo Consulting (UK) Limited
Address:

Compass House Vision Park Histon c/o Cr360 – UL International



Cambridge

CB24 9BZ

England United Kingdom




Code/Term Type
Cranioplasty plate non-alterableCranioplasty plate non-alterableClass IIb
Craniofacial fixation plate non-bioabsorbableCraniofacial fixation plate non-bioabsorbableClass IIb
Cranioplasty plate screwCranioplasty plate screwClass IIb
Bone/joint surgical power tool motorized handpiece/set electric single-useBone/joint surgical power tool motorized handpiece/set electric single-useClass IIa
Instrument tray reusableInstrument tray reusableClass I
Fluted surgical drill bit reusableFluted surgical drill bit reusableClass I
Surgical screwdriver reusableSurgical screwdriver reusableClass I
Manual orthopaedic bender reusableManual orthopaedic bender reusableClass I
Orthopaedic implantable-device cutterOrthopaedic implantable-device cutterClass I
Surgical instrument handle non-torque-limitingSurgical instrument handle non-torque-limitingClass I
Surgical implant handling forcepsSurgical implant handling forcepsClass I
Tendon/ligament bone anchor non-bioabsorbableTendon/ligament bone anchor non-bioabsorbableClass IIb
Tendon/ligament bone anchor non-bioabsorbableTendon/ligament bone anchor non-bioabsorbableClass IIb
Tendon/ligament bone anchor bioabsorbableTendon/ligament bone anchor bioabsorbableClass III