ACCURIS 71236026
GUDID 03596010513281
ACCURIS TIBIAL ONLAY BASE TRIAL EXTRA SMALL RM/LL
Smith & Nephew, Inc.
Knee tibia prosthesis trial| Primary Device ID | 03596010513281 |
| NIH Device Record Key | 8b8d67c5-2034-450d-9ac8-ee44589e2d2d |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACCURIS |
| Version Model Number | 71236026 |
| Catalog Number | 71236026 |
| 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)821-5700 |
| 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 | |
| Phone | +1(800)238-7538 |
| GUDID@SMITH-NEPHEW.COM |
Device Identifiers
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 03596010513281 [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 |
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
[03596010513281]
Moist Heat or Steam Sterilization
Device Entry Metadata
| Public Version Status | Update |
| Device Record Status | Published |
| Public Version Number | 5 |
| Public Version Date | 2020-01-31 |
| Device Publish Date | 2015-08-25 |
On-Brand Devices [ACCURIS]
| 00885556057162 | ACCURIS UNI TIBIAL INLAY TRIAL 34 X 7MM |
| 00885556018446 | ACCURIS-POWER CORD-NORTH AMERICA |
| 03596010477088 | ACCURIS-TIBIAL INSERT TRIALS EXTRA LARGE/MAGNUM 12 |
| 03596010477071 | ACCURIS-TIBIAL INSERT TRIALS EXTRA LARGE/MAGNUM 11 |
| 03596010477064 | ACCURIS-TIBIAL INSERT TRIALS EXTRA LARGE/MAGNUM 10 |
| 03596010477057 | ACCURIS-TIBIAL INSERT TRIALS EXTRA LARGE/MAGNUM 9 |
| 03596010477040 | ACCURIS-TIBIAL INSERT TRIALS EXTRA LARGE/MAGNUM 8 |
| 03596010477033 | ACCURIS-TIBIAL INSERT TRIALS MEDIUM/LARGE 12 |
| 03596010477026 | ACCURIS-TIBIAL INSERT TRIALS MEDIUM/LARGE 11 |
| 03596010477019 | ACCURIS-TIBIAL INSERT TRIALS MEDIUM/LARGE 10 |
| 03596010477002 | ACCURIS-TIBIAL INSERT TRIALS MEDIUM/LARGE 9 |
| 03596010476999 | ACCURIS-TIBIAL INSERT TRIALS MEDIUM/LARGE 8 |
| 03596010476982 | ACCURIS-TIBIAL INSERT TRIALS EXTRA SMALL/SMALL 12 |
| 03596010476975 | ACCURIS-TIBIAL INSERT TRIALS EXTRA SMALL/SMALL 11 |
| 03596010476968 | ACCURIS-TIBIAL INSERT TRIALS X SMALL/SMALL 10 |
| 03596010476951 | ACCURIS-TIBIAL INSERT TRIALS EXTRA SMALL/SMALL 9 |
| 03596010476944 | ACCURIS-TIBIAL INSERT TRIALS EXTRA SMALL/SMALL 8 |
| 03596010589897 | ACCURIS TIBIAL INSERT HANDLE |
| 03596010513502 | ACCURIS FEMORAL SIZER/DRILL GUIDE MAGNUM PLUS |
| 03596010513496 | ACCURIS FEMORAL SIZER/DRILL GUIDE MAGNUM |
| 03596010513489 | ACCURIS FEMORAL SIZER/DRILL GUIDE XLARGE |
| 03596010513472 | ACCURIS FEMORAL SIZER/DRILL GUIDE LARGE |
| 03596010513465 | ACCURIS FEMORAL SIZER/DRILL GUIDE MEDIUM |
| 03596010513458 | ACCURIS FEMORAL SIZER/DRILL GUIDE SMALL |
| 03596010513441 | ACCURIS FEMORAL SIZER/DRILL GUIDE XSMALL |
| 03596010513434 | ACCURIS FEMORAL TRIAL HANDLE |
| 03596010513427 | ACCURIS SIZER/GUIDE BLOCK X-LARGE/MAG/MAG |
| 03596010513410 | ACCURIS SIZER/GUIDE BLOCK MED/LARGE |
| 03596010513403 | ACCURIS SIZER/GUIDE BLOCK X-SMALL/SMALL |
| 03596010513397 | ACCURIS TIBIAL ONLAY BASE TRIAL MAGNUM LM/RL |
| 03596010513380 | ACCURIS TIBIAL ONLAY BASE TRIAL EXTRA LARGE LM/RL |
| 03596010513373 | ACCURIS TIBIAL ONLAY BASE TRIAL LARGE LM/RL |
| 03596010513366 | ACCURIS TIBIAL ONLAY BASE TRIAL MEDIUM LM/RL |
| 03596010513359 | ACCURIS TIBIAL ONLAY BASE TRIAL SMALL LM/RL |
| 03596010513342 | ACCURIS TIBIAL ONLAY BASE TRIAL EXTRA SMALL LM/RL |
| 03596010513335 | ACCURIS TIBIAL ONLAY BASE TRIAL MAGNUM RM/LL |
| 03596010513328 | ACCURIS TIBIAL ONLAY BASE TRIAL XLARGE RM/LL |
| 03596010513311 | ACCURIS TIBIAL ONLAY BASE TRIAL LARGE RM/LL |
| 03596010513304 | ACCURIS TIBIAL ONLAY BASE TRIAL MEDIUM RM/LL |
| 03596010513298 | ACCURIS TIBIAL ONLAY BASE TRIAL SMALL RM/LL |
| 03596010513281 | ACCURIS TIBIAL ONLAY BASE TRIAL EXTRA SMALL RM/LL |
| 03596010478177 | ACCURIS-POWER CORD-ITALY |
| 03596010478009 | ACCURIS-POWER CORD-WEST/EAST EUROPE |
| 03596010477422 | ACCURIS FEMORAL REAMER RM/LL |
| 03596010477415 | ACCURIS FEMORAL REAMER LM/RL |
| 03596010477255 | ACCURIS STERILIZATION TRAY NO.4 |
| 03596010477200 | ACCURIS-TIBIAL SCREW TAP |
| 03596010477194 | ACCURIS-TIBIAL BASE IMPACTOR CEMENT PRESSURIZER |
| 03596010477187 | ACCURIS - MODULAR IMPACTOR HEAD |
| 03596010477170 | ACCURIS-TIBIAL FIN PUNCH RM/LL |
Trademark Results [ACCURIS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ACCURIS 97873509 not registered Live/Pending |
Allium Buyer LLC 2023-04-05 |
 ACCURIS 77194429 3380787 Dead/Cancelled |
SignWarehouse, Inc. 2007-05-31 |
 ACCURIS 76298887 2780200 Dead/Cancelled |
Smith & Nephew, Inc. 2001-08-14 |
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