| Primary Device ID | 07630971258419 |
| NIH Device Record Key | 77a599e3-aa70-4a9b-a7b2-a6a8880a694c |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | GMK Hinge and Revision TiNbN coated |
| Version Model Number | 02.07.SCP10 |
| Company DUNS | 488227125 |
| Company Name | Medacta International SA |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | true |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 07630971258419 [Primary] |
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer |
| Steralize Prior To Use | false |
| Device Is Sterile | true |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2021-03-12 |
| Device Publish Date | 2021-03-04 |
| 07630971258549 | GMK-HINGE Hinge Post Extension 26 mm -TiNbN coated |
| 07630971258532 | GMK-HINGE Hinge Post Extension 23 mm -TiNbN coated |
| 07630971258525 | GMK-HINGE Hinge Post Extension 20 mm -TiNbN coated |
| 07630971258518 | GMK-HINGE Hinge Post Extension 17 mm -TiNbN coated |
| 07630971258501 | GMK-HINGE Hinge Post Extension 14 mm -TiNbN coated |
| 07630971258495 | GMK-HINGE Hinge Post Extension 12 mm -TiNbN coated |
| 07630971258488 | GMK-HINGE Hinge Post Extension 10 mm -TiNbN coated |
| 07630971258471 | TiNbN coated SC Peg - 26mm |
| 07630971258464 | TiNbN coated SC Peg - 23mm |
| 07630971258457 | TiNbN coated SC Peg - 20mm |
| 07630971258440 | TiNbN coated SC Peg - 17mm |
| 07630971258433 | TiNbN coated SC Peg - 14mm |
| 07630971258426 | TiNbN coated SC Peg - 12mm |
| 07630971258419 | TiNbN coated SC Peg - 10mm |
| 07630971258280 | TiNbN coated Revision Tibial Tray size 6 Right |
| 07630971258273 | TiNbN coated Revision Tibial Tray size 6 Left |
| 07630971258266 | TiNbN coated Revision Tibial Tray size 5 Right |
| 07630971258259 | TiNbN coated Revision Tibial Tray size 5 Left |
| 07630971258242 | TiNbN coated Revision Tibial Tray size 4 Right |
| 07630971258235 | TiNbN coated Revision Tibial Tray size 4 Left |
| 07630971258228 | TiNbN coated Revision Tibial Tray size 3 Right |
| 07630971258211 | TiNbN coated Revision Tibial Tray size 3 Left |
| 07630971258204 | TiNbN coated Revision Tibial Tray size 2 Right |
| 07630971258198 | TiNbN coated Revision Tibial Tray size 2 Left |
| 07630971258181 | TiNbN coated Revision Tibial Tray size 1 Right |
| 07630971258174 | TiNbN coated Revision Tibial Tray size 1 Left |
| 07630971258167 | TiNbN coated Femur Revision STD # 6 R |
| 07630971258150 | TiNbN coated Femur Revision STD # 6 L |
| 07630971258143 | TiNbN coated Femur Revision STD # 5 R |
| 07630971258136 | TiNbN coated Femur Revision STD # 5 L |
| 07630971258129 | TiNbN coated Femur Revision STD # 4 R |
| 07630971258112 | TiNbN coated Femur Revision STD # 4 L |
| 07630971258105 | TiNbN coated Femur Revision STD # 3 R |
| 07630971258099 | TiNbN coated Femur Revision STD # 3 L |
| 07630971258082 | TiNbN coated Femur Revision STD # 2 R |
| 07630971258075 | TiNbN coated Femur Revision STD # 2 L |
| 07630971258068 | TiNbN coated Femur Revision STD # 1 R |
| 07630971258051 | TiNbN coated Femur Revision STD # 1 L |
| 07630971258044 | TiNbN coated Femur Revision PS # 6 R |
| 07630971258037 | TiNbN coated Femur Revision PS # 6 L |
| 07630971258020 | TiNbN coated Femur Revision PS # 5 R |
| 07630971258013 | TiNbN coated Femur Revision PS # 5 L |
| 07630971258006 | TiNbN coated Femur Revision PS # 4 R |
| 07630971257993 | TiNbN coated Femur Revision PS # 4 L |
| 07630971257986 | TiNbN coated Femur Revision PS # 3 R |
| 07630971257979 | TiNbN coated Femur Revision PS # 3 L |
| 07630971257962 | TiNbN coated Femur Revision PS # 2 R |
| 07630971257955 | TiNbN coated Femur Revision PS # 2 L |
| 07630971257948 | TiNbN coated Femur Revision PS # 1 R |
| 07630971257931 | TiNbN coated Femur Revision PS # 1 L |