OXINIUM 71215036
GUDID 03596010490988
Oxinium UNI FEMORAL FINAL TRIAL Magnum PLUS
Smith & Nephew, Inc.
Knee femur prosthesis trial| Primary Device ID | 03596010490988 |
| NIH Device Record Key | a62dc50f-46f8-48ef-862d-0a788a5c6b2b |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | OXINIUM |
| Version Model Number | 71215036 |
| Catalog Number | 71215036 |
| Company DUNS | 109903521 |
| Company Name | Smith & Nephew, 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 | false |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
Customer Support Contacts
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03596010490988 [Primary] |
FDA Pre-market Approvals/Notifications & deNovo
- Premarket Notification: K113038
FDA Product Code
| HSX | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER |
Sterilization
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
[03596010490988]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-11-03 |
| Device Publish Date | 2015-08-25 |
On-Brand Devices [OXINIUM]
| 00885556689394 | OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +16 |
| 00885556533895 | OXINIUM 10/12 TAPER FEMORAL HEAD 36MM +5 |
| 00885556533888 | OXINIUM 10/12 TAPER FEMORAL HEAD 36MM +0 |
| 00885556533802 | OXINIUM 10/12 TAPER FEMORAL HEAD 36MM -5 |
| 00885556112540 | OXINIUM FEMORAL HEAD 10/12 22MM -3 EXT |
| 00885556112533 | OXINIUM FEMORAL HEAD 10/12 22MM +0 EXT |
| 00885556112526 | OXINIUM FEMORAL HEAD 10/12 22MM +3 EXT |
| 00885556112519 | OXINIUM FEMORAL HEAD 10/12 26MM -5 EXT |
| 00885556112502 | OXINIUM FEMORAL HEAD 10/12 26MM +0 EXT |
| 00885556112496 | OXINIUM FEMORAL HEAD 10/12 26MM +5 EXT |
| 00885556112489 | OXINIUM FEMORAL HEAD 10/12 28MM -5 EXT |
| 00885556112472 | OXINIUM FEMORAL HEAD 10/12 28MM +0 EXT |
| 00885556112465 | OXINIUM FEMORAL HEAD 10/12 28MM +5 EXT |
| 00885556112458 | OXINIUM FEMORAL HEAD 10/12 32MM -5 EXT |
| 00885556112441 | OXINIUM FEMORAL HEAD 10/12 32MM +0 EXT |
| 00885556112434 | OXINIUM FEMORAL HEAD 10/12 32MM +5 EXT |
| 00885556112410 | 40MM OXINIUM MODULAR FEMORAL HEAD |
| 03596010652003 | 44MM OXINIUM MODULAR FEMORAL HEAD |
| 03596010537492 | OXINIUM FEMORAL HEAD 12/14 TAPER 22 MM +12 |
| 03596010534774 | OXINIUM UNIPOLAR HEAD 55MM OD |
| 03596010534767 | OXINIUM UNIPOLAR HEAD 54MM OD |
| 03596010534750 | OXINIUM UNIPOLAR HEAD 53MM OD |
| 03596010534743 | OXINIUM UNIPOLAR HEAD 52MM OD |
| 03596010534736 | OXINIUM UNIPOLAR HEAD 51MM OD |
| 03596010534729 | OXINIUM UNIPOLAR HEAD 50MM OD |
| 03596010534712 | OXINIUM UNIPOLAR HEAD 49MM OD |
| 03596010534705 | OXINIUM UNIPOLAR HEAD 48MM OD |
| 03596010534699 | OXINIUM UNIPOLAR HEAD 47MM OD |
| 03596010534682 | OXINIUM UNIPOLAR HEAD 46MM OD |
| 03596010534675 | OXINIUM UNIPOLAR HEAD 45MM OD |
| 03596010534668 | OXINIUM UNIPOLAR HEAD 44MM OD |
| 03596010534651 | OXINIUM UNIPOLAR HEAD 43MM OD |
| 03596010534644 | OXINIUM UNIPOLAR HEAD 42MM OD |
| 03596010534637 | OXINIUM UNIPOLAR HEAD 41MM OD |
| 03596010534620 | OXINIUM UNIPOLAR HEAD 40MM OD |
| 03596010525185 | OXINIUM FEMORAL HEAD 12/14 TAPER 32 MM +16 |
| 03596010520449 | OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM XL/+12 |
| 03596010516275 | OXINIUM FEMORAL HEAD 12/14 TAPER 32 MM +12 |
| 03596010514233 | OXINIUM FEMORAL HEAD 12/14 TAPER 26 MM +12 |
| 03596010502285 | OXINIUM FEM HEAD 14/16 TPR 36MM +8 NECK |
| 03596010502278 | OXINIUM FEM HEAD 14/16 TPR 36MM +4 NECK |
| 03596010502261 | OXINIUM FEM HEAD 14/16 TPR 36MM +0 NECK |
| 03596010502254 | OXINIUM FEM HEAD 14/16 TPR 28MM +8 NECK |
| 03596010502247 | OXINIUM FEM HEAD 14/16 TPR 28MM +4 NECK |
| 03596010502230 | OXINIUM FEM HEAD 14/16 TPR 28MM +0 NECK |
| 03596010502032 | OXINIUM FEM HEAD 14/16 TPR 32MM +8 NECK |
| 03596010502025 | OXINIUM FEM HEAD 14/16 TPR 32MM +4 NECK |
| 03596010502018 | OXINIUM FEM HEAD 14/16 TPR 32MM +0 NECK |
| 03596010491060 | OXINIUM UNI INSTRUMENT TRAY |
| 03596010488916 | OXINIUM FEMORAL HEAD 12/14 TAPER 26 MM +8 |
Trademark Results [OXINIUM]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 OXINIUM 78608023 not registered Dead/Abandoned |
Smith & Nephew, Inc. 2005-04-13 |
 OXINIUM 76297274 2772259 Live/Registered |
Smith & Nephew, Inc. 2001-08-08 |
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