Salto Talaris Total Ankle Prosthesis LJU215T

GUDID 00885556831816

SALTO TAL PE INSERT RIGHT SZ 0 8 MM THICKNESS

Smith & Nephew, Inc.

Fixed-bearing total ankle prosthesis

• Primary Device ID: 00885556831816
• NIH Device Record Key: 47ad81c8-bae0-404b-9dac-444c402ca00d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Salto Talaris Total Ankle Prosthesis
• Version Model Number: LJU215T
• Catalog Number: LJU215T
• 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

Customer Support Contacts

• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556831816 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K060544

FDA Product Code

• HSN: PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-09-07
• Device Publish Date: 2022-12-21

On-Brand Devices [Salto Talaris Total Ankle Prosthesis]

• 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