Equinoxe® 324-44-13
GUDID 10885862622563
Humeral Liner, Constrained
Exactech, Inc.
Polyethylene reverse shoulder prosthesis cup| Primary Device ID | 10885862622563 |
| NIH Device Record Key | 1c2439b1-3d2a-4eef-b1df-1aadbfd2b51e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Equinoxe® |
| Version Model Number | 324-44-13 |
| Catalog Number | 324-44-13 |
| Company DUNS | 157565946 |
| Company Name | Exactech, Inc. |
| 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 | false |
| Serial Number | true |
| 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 Dimensions
| Angle | 135 degree |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Angle | 135 degree |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Angle | 135 degree |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Angle | 135 degree |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Angle | 135 degree |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Angle | 135 degree |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Angle | 135 degree |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Angle | 135 degree |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Angle | 135 degree |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Angle | 135 degree |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Angle | 135 degree |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Angle | 135 degree |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Angle | 135 degree |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Angle | 135 degree |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Angle | 135 degree |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Angle | 135 degree |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Angle | 135 degree |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Angle | 135 degree |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
| Device Size Text, specify | 0 |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 10885862622563 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K223833
FDA Product Code
| KWS | PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED |
Sterilization
| Steralize Prior To Use | false |
| Device Is Sterile | true |
Device Entry Metadata
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-12-06 |
| Device Publish Date | 2023-11-28 |
On-Brand Devices [Equinoxe®]
| 10885862622600 | Humeral Liner, Constrained |
| 10885862622594 | Humeral Liner, Constrained |
| 10885862622587 | Humeral Liner |
| 10885862622570 | Humeral Liner |
| 10885862622563 | Humeral Liner, Constrained |
| 10885862622556 | Humeral Liner, Constrained |
| 10885862622549 | Humeral Liner |
| 10885862622532 | Humeral Liner |
| 10885862622525 | Humeral Liner, Constrained |
| 10885862622518 | Humeral Liner, Constrained |
| 10885862622501 | Humeral Liner |
| 10885862622495 | Humeral Liner |
| 10885862622488 | Humeral Liner, Constrained |
| 10885862622471 | Humeral Liner, Constrained |
| 10885862622464 | Humeral Liner |
| 10885862622457 | Humeral Liner |
| 10885862622440 | Humeral Liner, Constrained |
| 10885862622433 | Humeral Liner, Constrained |
| 10885862622426 | Humeral Liner |
| 10885862622419 | Humeral Liner |
| 10885862622402 | Humeral Liner, Constrained |
| 10885862622396 | Humeral Liner, Constrained |
| 10885862622389 | Humeral Liner |
| 10885862622372 | Humeral Liner |
| 10885862606952 | Humeral Liner, Constrained |
| 10885862594020 | Humeral Liner, Constrained |
| 10885862594013 | Humeral Liner |
| 10885862594006 | Humeral Liner |
| 10885862593993 | Humeral Liner, Constrained |
| 10885862593986 | Humeral Liner, Constrained |
| 10885862593979 | Humeral Liner |
| 10885862593962 | Humeral Liner |
| 10885862593955 | Humeral Liner, Constrained |
| 10885862593948 | Humeral Liner, Constrained |
| 10885862593931 | Humeral Liner |
| 10885862593924 | Humeral Liner |
| 10885862593917 | Humeral Liner, Constrained |
| 10885862593900 | Humeral Liner, Constrained |
| 10885862593894 | Humeral Liner |
| 10885862593887 | Humeral Liner |
| 10885862593870 | Humeral Liner, Constrained |
| 10885862593863 | Humeral Liner, Constrained |
| 10885862593856 | Humeral Liner |
| 10885862593849 | Humeral Liner |
| 10885862593832 | Humeral Liner, Constrained |
| 10885862593825 | Humeral Liner, Constrained |
| 10885862593818 | Humeral Liner |
| 10885862593801 | Humeral Liner |
| 10885862593795 | Humeral Adapter Tray |
| 10885862593788 | Humeral Adapter Tray |
Trademark Results [Equinoxe]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 EQUINOXE 76533714 3121160 Live/Registered |
Exactech, Inc. 2003-07-31 |
 EQUINOXE 74669086 2299128 Dead/Cancelled |
Caran d'Ache SA 1995-05-02 |
 EQUINOXE 74551690 2021609 Dead/Cancelled |
EQUINOXE 1994-07-20 |
 EQUINOXE 74284084 1822644 Dead/Cancelled |
C.M.S. MUSIC INC. 1992-06-12 |
 EQUINOXE 74283205 1831282 Dead/Cancelled |
C.M.S. MUSIC INC. 1992-06-09 |
 EQUINOXE 73828780 1606586 Dead/Cancelled |
ETABLISSEMENTS DE LOISY & GELET 1989-10-02 |
 EQUINOXE 73734775 1550376 Live/Registered |
ETABLISSEMENTS DE LOISY & GELET 1988-06-17 |
 EQUINOXE 73716743 1535166 Dead/Cancelled |
ALLIA 1988-03-14 |
 EQUINOXE 73285261 1248395 Dead/Cancelled |
Lainiere de Roubaix 1980-11-10 |
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