Salto Talaris Total Ankle Prosthesis LJU285T

GUDID 00885556832134

SALTO TALARIS. INSERT. SIZE 3. LEFT. TH8

Smith & Nephew, Inc.

Fixed-bearing total ankle prosthesis
Primary Device ID00885556832134
NIH Device Record Keye5599e0c-4ac2-4272-923f-04b1e87e35c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameSalto Talaris Total Ankle Prosthesis
Version Model NumberLJU285T
Catalog NumberLJU285T
Company DUNS045483575
Company NameSmith & Nephew, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM
Phone+1(800)238-7538
EmailGUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing AgencyDevice ID
GS100885556832134 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HSNPROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2023-09-07
Device Publish Date2022-12-21

On-Brand Devices [Salto Talaris Total Ankle Prosthesis]

00885556842188INTEGRA XT. REMOVER. STABILIZATION PEG
00885556834183HEX 3.5 SCREWDRIVER
00885556834176TALAR TRIAL. FLAT CUT. SIZE 0. LEFT
00885556834169TALAR TRIAL. FLAT CUT. SIZE 0. RIGHT
00885556834152TIBIAL IMPLANT EXTRACTOR
00885556834138SALTO TALARIS. INSERT ASSEMBLY BENCH
00885556834114SALTO TALARIS. INSERT EXTRACTOR
00885556834107SALTO TALARIS. TIBIAL TRIAL. XL. SIZE 3XL
00885556834091SALTO TALARIS. TIBIAL TRIAL. XL. SIZE 2XL
00885556834084SALTO TALARIS. TIBIAL TRIAL. XL. SIZE 1XL
00885556834077SALTO TALARIS. TIBIAL TRIAL. XL. SIZE 0XL
00885556833889SALTO TALARIS. EXTRACTION ADAPTOR. FLAT CUT
00885556833872SALTO TALARIS. DRILL. TALAR FLANGE. FLAT CUT
00885556833858SALTO TALARIS. BELL SAW REAMER. FLAT CUT
00885556833841SALTO TALARIS. TALAR CUT GUIDE. FLAT CUT
00885556833834SALTO TALARIS. TRIAL INSERT. SIZE 3. LEFT. TH17
00885556833827SALTO TALARIS. TRIAL INSERT. SIZE 3. LEFT. TH15
00885556833810SALTO TALARIS. ANT CHAMFER BUSH. WIDE. STEP 2
00885556833803SALTO TALARIS. 3 DEGREE BLOCK. TIBIAL ALIGNMENT
00885556833780SALTO TALARIS. TALAR POSITION PLUG. SIZE 2.3
00885556833766SALTO TALARIS. INSERT ASSEMBLY PRESS. PRIMARY
00885556833650SALTO TALARIS. TIBIAL CUT GUIDE. SIZE 3
00885556833643SALTO TALARIS. TIBIAL CUT GUIDE. SIZE 2
00885556833636SALTO TALARIS. TIBIAL CUT GUIDE. SIZE 1
00885556833629SALTO TALARIS. TIBIAL CUT GUIDE. SIZE 0
00885556833612SALTO TALARIS. TALAR POSITION PLUG. SIZE 0.1
00885556833018TIBIAL KEEL GRADUATED OSTEOTOME
00885556833001SALTO TALARIS. TIBIAL TRIAL. SIZE 3
00885556832998SALTO TALARIS. TIBIAL TRIAL. SIZE 2
00885556832981SALTO TALARIS. TIBIAL TRIAL. SIZE 1
00885556832974AUGMENT. THICKNESS 3 MM
00885556832967AUGMENT. THICKNESS 2 MM
00885556832950AUGMENT. THICKNESS 1 MM
00885556832943SALTO TALARIS. TIBIAL TRIAL. SIZE 0
00885556832936SIZE 0 DRILLING GUIDE
00885556832929POSTERIOR TALAR RESECTION GUIDE. SZ 1/2/3
00885556832912POSTERIOR TALAR RESECTION GUIDE. SZ 0
00885556832905TIBIAL RESECTION GUIDE SIZE 3
00885556832899TIBIAL RESECTION GUIDE SIZE 2
00885556832882TIBIAL RESECTION GUIDE SIZE 1
00885556832875TIBIAL RESECTION GUIDE SIZE 0
00885556832851REMOVABLE HANDLE
00885556832844PIN PUSHER
00885556832837SALTO TALARIS. TALAR GAUGE. SIZE 2/3
00885556832820SALTO TALARIS. DILL BIT. SIZE 0. TALAR STEM
00885556832813SALTO TALARIS. TIBIAL IMPACTOR
00885556832806SALTO TALARIS. PIN PULLER
00885556832790SLAP HAMMER
00885556832783SALTO TALARIS. OSTEOTOME. THIN
00885556832776TIBIAL PLUG REVISION OSTEOTOME

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