Primary Device ID | 00885556832011 |
NIH Device Record Key | 78087493-e6f9-47c5-b506-1c51f70a123f |
Commercial Distribution Status | In Commercial Distribution |
Brand Name | Salto Talaris Total Ankle Prosthesis |
Version Model Number | LJU255T |
Catalog Number | LJU255T |
Company DUNS | 045483575 |
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 | 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)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 | 00885556832011 [Primary] |
HSN | PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER |
Steralize Prior To Use | false |
Device Is Sterile | true |
Public Version Status | Update |
Device Record Status | Published |
Public Version Number | 2 |
Public Version Date | 2023-09-07 |
Device Publish Date | 2022-12-21 |
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 |