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-alterable | Cranioplasty plate non-alterable | Class IIb
|
| Craniofacial fixation plate non-bioabsorbable | Craniofacial fixation plate non-bioabsorbable | Class IIb
|
| Cranioplasty plate screw | Cranioplasty plate screw | Class IIb
|
| Bone/joint surgical power tool motorized handpiece/set electric single-use | Bone/joint surgical power tool motorized handpiece/set electric single-use | Class IIa
|
| Instrument tray reusable | Instrument tray reusable | Class I
|
| Fluted surgical drill bit reusable | Fluted surgical drill bit reusable | Class I
|
| Surgical screwdriver reusable | Surgical screwdriver reusable | Class I
|
| Manual orthopaedic bender reusable | Manual orthopaedic bender reusable | Class I
|
| Orthopaedic implantable-device cutter | Orthopaedic implantable-device cutter | Class I
|
| Surgical instrument handle non-torque-limiting | Surgical instrument handle non-torque-limiting | Class I
|
| Surgical implant handling forceps | Surgical implant handling forceps | Class I
|
| Tendon/ligament bone anchor non-bioabsorbable | Tendon/ligament bone anchor non-bioabsorbable | Class IIb
|
| Tendon/ligament bone anchor non-bioabsorbable | Tendon/ligament bone anchor non-bioabsorbable | Class IIb
|
| Tendon/ligament bone anchor bioabsorbable | Tendon/ligament bone anchor bioabsorbable | Class III
|