| Primary Device ID | 00841690128908 |
| NIH Device Record Key | fc2ac560-f39f-49e5-b349-df1b4bd2d1bf |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | APEX Knee System |
| Version Model Number | KC-55244 |
| Catalog Number | KC-55244 |
| Company DUNS | 061339651 |
| Company Name | Omnilife Science, Inc |
| Device Count | 1 |
| DM Exempt | true |
| 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 |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com | |
| Phone | +1(800)448-6664 |
| CS@omnils.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00841690128908 [Primary] |
| JWH | PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER |
| Steralize Prior To Use | true |
| Device Is Sterile | true |
[00841690128908]
Ethylene Oxide
[00841690128908]
Ethylene Oxide
[00841690128908]
Ethylene Oxide
[00841690128908]
Ethylene Oxide
[00841690128908]
Ethylene Oxide
[00841690128908]
Ethylene Oxide
[00841690128908]
Ethylene Oxide
[00841690128908]
Ethylene Oxide
[00841690128908]
Ethylene Oxide
[00841690128908]
Ethylene Oxide
[00841690128908]
Ethylene Oxide
[00841690128908]
Ethylene Oxide
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2018-04-16 |
| Device Publish Date | 2018-03-15 |
| 00841690130123 | Retaining Bolt, PS-R Insert, Revision Tibia Baseplate, 28mm |
| 00841690130116 | Retaining Bolt, PS-R Insert, Revision Tibia Baseplate, 24mm |
| 00841690130109 | Retaining Bolt, PS-R Insert, Revision Tibia Baseplate, 20mm |
| 00841690130093 | Retaining Bolt, PS-R Insert, Revision Tibia Baseplate, 18mm |
| 00841690130086 | Retaining Bolt, PS-R Insert, Revision Tibia Baseplate, 16mm |
| 00841690130079 | Retaining Bolt, PS-R Insert, Revision Tibia Baseplate, 14mm |
| 00841690130062 | Retaining Bolt, PS-R Insert, Revision Tibia Baseplate, 12mm |
| 00841690130055 | Retaining Bolt, PS-R Insert, Revision Tibia Baseplate, 11mm |
| 00841690130048 | Retaining Bolt, PS-R Insert, Revision Tibia Baseplate, 10mm |
| 00841690130031 | Retaining Bolt, PS or PS-C Insert, Revision Tibia Baseplate, 20mm |
| 00841690130024 | Retaining Bolt, PS or PS-C Insert, Revision Tibia Baseplate, 18mm |
| 00841690130017 | Retaining Bolt, PS or PS-C Insert, Revision Tibia Baseplate, 16mm |
| 00841690130000 | Retaining Bolt, PS or PS-C Insert, Revision Tibia Baseplate, 14mm |
| 00841690129998 | Retaining Bolt, PS or PS-C Insert, Revision Tibia Baseplate, 13mm |
| 00841690129981 | Retaining Bolt, PS or PS-C Insert, Revision Tibia Baseplate, 12mm |
| 00841690129974 | Retaining Bolt, PS or PS-C Insert, Revision Tibia Baseplate, 11mm |
| 00841690129967 | Retaining Bolt, PS or PS-C Insert, Revision Tibia Baseplate, 10mm |
| 00841690129950 | Retaining Bolt, Congruent or Ultra Insert, Revision Tibia Baseplate |
| 00841690129745 | Revision Tibial Baseplate Size 1 |
| 00841690129738 | Revision Tibial Baseplate Size 6 |
| 00841690129721 | Revision Tibial Baseplate Size 5 |
| 00841690129714 | Revision Tibial Baseplate Size 4 |
| 00841690129707 | Revision Tibial Baseplate Size 3 |
| 00841690129691 | Revision Tibial Baseplate Size 2 |
| 00841690129622 | PS femur, cemented Size 6+ Right |
| 00841690129615 | PS femur, cemented Size 6+ Left |
| 00841690129608 | PS femur, cemented Size 5+ Right |
| 00841690129592 | PS femur, cemented Size 5+ Left |
| 00841690129547 | CR Femoral Cemented, Size 6+ Right |
| 00841690129530 | CR Femoral Cemented, Size 6+ Left |
| 00841690129523 | CR Femoral Cemented, Size 5+ Right |
| 00841690129516 | CR Femoral Cemented, Size 5+ Left |
| 00841690128977 | Stem Retaining Bolt, Revision Femur |
| 00841690128960 | Femoral Augment, Notched Posterior, Size 1, 10mm |
| 00841690128953 | Femoral Augment, Notched Posterior, Size 5+, 10mm |
| 00841690128946 | Femoral Augment, Notched Posterior, Size 4+, 10mm |
| 00841690128939 | Femoral Augment, Notched Posterior, Size 3+, 10mm |
| 00841690128922 | Femoral Augment, Notched Posterior, Size 2+, 10mm |
| 00841690128915 | Femoral Augment, Notched Posterior, Size 1+, 10mm |
| 00841690128908 | Revision Fluted Offset Stem 24mm x 150mm x 4mm |
| 00841690128892 | Revision Fluted Offset Stem 24mm x 100mm x 4mm |
| 00841690128885 | Revision Fluted Stem 24mm x 150mm |
| 00841690128878 | Revision Fluted Stem 24mm x 100mm |
| 00841690128861 | Revision Fluted Offset Stem 22mm x 150mm x 4mm |
| 00841690128854 | Revision Fluted Offset Stem 22mm x 100mm x 4mm |
| 00841690128847 | Revision Fluted Stem 22mm x 150mm |
| 00841690128830 | Revision Fluted Stem 22mm x 100mm |
| 00841690128823 | Revision Fluted Offset Stem 20mm x 150mm x 4mm |
| 00841690128816 | Revision Fluted Offset Stem 20mm x 100mm x 4mm |
| 00841690128809 | Revision Fluted Stem 20mm x 150mm |