Primary Device ID | 07630345729590 |
NIH Device Record Key | 01f65e8b-a7b6-46df-a936-5815bce8c3f0 |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | GMK Total Knee System |
Version Model Number | 02.07.12055R |
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 | 07630345729590 [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 | 2021-08-19 |
Device Publish Date | 2021-08-11 |
07630040711654 | GMK Sphere Tibial tray fixed cemented #t4i3 R TiNbN coated |
07630040711647 | GMK Sphere Tibial tray fixed cemented #t4i3 L TiNbN coated |
07630040711630 | GMK Sphere Tibial tray fixed cemented #t3i4 R TiNbN coated |
07630040711623 | GMK Sphere Tibial tray fixed cemented #t3i4 L TiNbN coated |
07630040711616 | Femoral Component Sphere #6+ R TiNbN coated |
07630040711609 | Femoral Component Sphere #6+ L TiNbN coated |
07630040711593 | Femoral Component Sphere #5+ R TiNbN coated |
07630040711586 | Femoral Component Sphere #5+ L TiNbN coated |
07630040711579 | Femoral Component Sphere #4+ R TiNbN coated |
07630040711562 | Femoral Component Sphere #4+ L TiNbN coated |
07630040711555 | Femoral Component Sphere #3+ R TiNbN coated |
07630040711548 | Femoral Component Sphere #3+ L TiNbN coated |
07630040711531 | Femoral Component Sphere #2+ R TiNbN coated |
07630040711524 | Femoral Component Sphere #2+ L TiNbN coated |
07630040711517 | Femoral Component Sphere #1+ R TiNbN coated |
07630040711500 | Femoral Component Sphere #1+ L TiNbN coated |
07630040711494 | Femoral Component Sphere #7 R TiNbN coated |
07630040711487 | Femoral Component Sphere #7 L TiNbN coated |
07630040711470 | Femoral Component Sphere #6 R TiNbN coated |
07630040711463 | Femoral Component Sphere #6 L TiNbN coated |
07630040711456 | Femoral Component Sphere #5 R TiNbN coated |
07630040711449 | Femoral Component Sphere #5 L TiNbN coated |
07630040711432 | Femoral Component Sphere #4 R TiNbN coated |
07630040711425 | Femoral Component Sphere #4 L TiNbN coated |
07630040711418 | Femoral Component Sphere #3 R TiNbN coated |
07630040711401 | Femoral Component Sphere #3 L TiNbN coated |
07630040711395 | Femoral Component Sphere #2 R TiNbN coated |
07630040711388 | Femoral Component Sphere #2 L TiNbN coated |
07630040711371 | Femoral Component Sphere #1 R TiNbN coated |
07630040711364 | Femoral Component Sphere #1 L TiNbN coated |
07630030821875 | Tibial tray fixed cemented #6 R TiNbN coated |
07630030821868 | Tibial tray fixed cemented #6 L TiNbN coated |
07630030821851 | Tibial tray fixed cemented #5 R TiNbN coated |
07630030821844 | Tibial tray fixed cemented #5 L TiNbN coated |
07630030821837 | Tibial tray fixed cemented #4 R TiNbN coated |
07630030821820 | Tibial tray fixed cemented #4 L TiNbN coated |
07630030821813 | Tibial tray fixed cemented #3 R TiNbN coated |
07630030821806 | Tibial tray fixed cemented #3 L TiNbN coated |
07630030821790 | Tibial tray fixed cemented #2 R TiNbN coated |
07630030821783 | Tibial tray fixed cemented #2 L TiNbN coated |
07630030821776 | Tibial tray fixed cemented #1 R TiNbN coated |
07630030821769 | Tibial tray fixed cemented #1 L TiNbN coated |
07630345716194 | Femoral Component SPHERIKA Cemented S2+L |
07630345716187 | Femoral Component SPHERIKA Cemented S1+R |
07630345716170 | Femoral Component SPHERIKA Cemented S1+L |
07630345716163 | Femoral Component SPHERIKA Cemented S7R |
07630345716330 | Femoral Component SPHERIKA TiNbN coated Cemented S3L |
07630345716323 | Femoral Component SPHERIKA TiNbN coated Cemented S2R |
07630345716316 | Femoral Component SPHERIKA TiNbN coated Cemented S2L |
07630345716309 | Femoral Component SPHERIKA TiNbN coated Cemented S1R |