| Primary Device ID | 00885556833858 |
| NIH Device Record Key | 08f4de6b-dbcc-40b1-8a77-3714e4579625 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Salto Talaris Total Ankle Prosthesis |
| Version Model Number | MJU922T |
| Catalog Number | MJU922T |
| Company DUNS | 109903521 |
| Company Name | Smith & Nephew, Inc. |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| 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 |
| 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 Issuing Agency | Device ID |
|---|---|
| GS1 | 00885556833858 [Primary] |
| HTO | REAMER |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[00885556833858]
Moist Heat or Steam Sterilization
[00885556833858]
Moist Heat or Steam Sterilization
[00885556833858]
Moist Heat or Steam Sterilization
[00885556833858]
Moist Heat or Steam Sterilization
[00885556833858]
Moist Heat or Steam Sterilization
[00885556833858]
Moist Heat or Steam Sterilization
[00885556833858]
Moist Heat or Steam Sterilization
[00885556833858]
Moist Heat or Steam Sterilization
[00885556833858]
Moist Heat or Steam Sterilization
[00885556833858]
Moist Heat or Steam Sterilization
[00885556833858]
Moist Heat or Steam Sterilization
[00885556833858]
Moist Heat or Steam Sterilization
[00885556833858]
Moist Heat or Steam Sterilization
[00885556833858]
Moist Heat or Steam Sterilization
[00885556833858]
Moist Heat or Steam Sterilization
[00885556833858]
Moist Heat or Steam Sterilization
[00885556833858]
Moist Heat or Steam Sterilization
[00885556833858]
Moist Heat or Steam Sterilization
[00885556833858]
Moist Heat or Steam Sterilization
[00885556833858]
Moist Heat or Steam Sterilization
[00885556833858]
Moist Heat or Steam Sterilization
[00885556833858]
Moist Heat or Steam Sterilization
[00885556833858]
Moist Heat or Steam Sterilization
[00885556833858]
Moist Heat or Steam Sterilization
[00885556833858]
Moist Heat or Steam Sterilization
[00885556833858]
Moist Heat or Steam Sterilization
[00885556833858]
Moist Heat or Steam Sterilization
[00885556833858]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-02-10 |
| Device Publish Date | 2023-02-02 |
| 00885556842188 | INTEGRA XT. REMOVER. STABILIZATION PEG |
| 00885556834183 | HEX 3.5 SCREWDRIVER |
| 00885556834176 | TALAR TRIAL. FLAT CUT. SIZE 0. LEFT |
| 00885556834169 | TALAR TRIAL. FLAT CUT. SIZE 0. RIGHT |
| 00885556834152 | TIBIAL IMPLANT EXTRACTOR |
| 00885556834138 | SALTO TALARIS. INSERT ASSEMBLY BENCH |
| 00885556834114 | SALTO TALARIS. INSERT EXTRACTOR |
| 00885556834107 | SALTO TALARIS. TIBIAL TRIAL. XL. SIZE 3XL |
| 00885556834091 | SALTO TALARIS. TIBIAL TRIAL. XL. SIZE 2XL |
| 00885556834084 | SALTO TALARIS. TIBIAL TRIAL. XL. SIZE 1XL |
| 00885556834077 | SALTO TALARIS. TIBIAL TRIAL. XL. SIZE 0XL |
| 00885556833889 | SALTO TALARIS. EXTRACTION ADAPTOR. FLAT CUT |
| 00885556833872 | SALTO TALARIS. DRILL. TALAR FLANGE. FLAT CUT |
| 00885556833858 | SALTO TALARIS. BELL SAW REAMER. FLAT CUT |
| 00885556833841 | SALTO TALARIS. TALAR CUT GUIDE. FLAT CUT |
| 00885556833834 | SALTO TALARIS. TRIAL INSERT. SIZE 3. LEFT. TH17 |
| 00885556833827 | SALTO TALARIS. TRIAL INSERT. SIZE 3. LEFT. TH15 |
| 00885556833810 | SALTO TALARIS. ANT CHAMFER BUSH. WIDE. STEP 2 |
| 00885556833803 | SALTO TALARIS. 3 DEGREE BLOCK. TIBIAL ALIGNMENT |
| 00885556833780 | SALTO TALARIS. TALAR POSITION PLUG. SIZE 2.3 |
| 00885556833766 | SALTO TALARIS. INSERT ASSEMBLY PRESS. PRIMARY |
| 00885556833650 | SALTO TALARIS. TIBIAL CUT GUIDE. SIZE 3 |
| 00885556833643 | SALTO TALARIS. TIBIAL CUT GUIDE. SIZE 2 |
| 00885556833636 | SALTO TALARIS. TIBIAL CUT GUIDE. SIZE 1 |
| 00885556833629 | SALTO TALARIS. TIBIAL CUT GUIDE. SIZE 0 |
| 00885556833612 | SALTO TALARIS. TALAR POSITION PLUG. SIZE 0.1 |
| 00885556833018 | TIBIAL KEEL GRADUATED OSTEOTOME |
| 00885556833001 | SALTO TALARIS. TIBIAL TRIAL. SIZE 3 |
| 00885556832998 | SALTO TALARIS. TIBIAL TRIAL. SIZE 2 |
| 00885556832981 | SALTO TALARIS. TIBIAL TRIAL. SIZE 1 |
| 00885556832974 | AUGMENT. THICKNESS 3 MM |
| 00885556832967 | AUGMENT. THICKNESS 2 MM |
| 00885556832950 | AUGMENT. THICKNESS 1 MM |
| 00885556832943 | SALTO TALARIS. TIBIAL TRIAL. SIZE 0 |
| 00885556832936 | SIZE 0 DRILLING GUIDE |
| 00885556832929 | POSTERIOR TALAR RESECTION GUIDE. SZ 1/2/3 |
| 00885556832912 | POSTERIOR TALAR RESECTION GUIDE. SZ 0 |
| 00885556832905 | TIBIAL RESECTION GUIDE SIZE 3 |
| 00885556832899 | TIBIAL RESECTION GUIDE SIZE 2 |
| 00885556832882 | TIBIAL RESECTION GUIDE SIZE 1 |
| 00885556832875 | TIBIAL RESECTION GUIDE SIZE 0 |
| 00885556832851 | REMOVABLE HANDLE |
| 00885556832844 | PIN PUSHER |
| 00885556832837 | SALTO TALARIS. TALAR GAUGE. SIZE 2/3 |
| 00885556832820 | SALTO TALARIS. DILL BIT. SIZE 0. TALAR STEM |
| 00885556832813 | SALTO TALARIS. TIBIAL IMPACTOR |
| 00885556832806 | SALTO TALARIS. PIN PULLER |
| 00885556832790 | SLAP HAMMER |
| 00885556832783 | SALTO TALARIS. OSTEOTOME. THIN |
| 00885556832776 | TIBIAL PLUG REVISION OSTEOTOME |