Salto Talaris Total Ankle Prosthesis MJU373T

GUDID 00885556832905

TIBIAL RESECTION GUIDE SIZE 3

Smith & Nephew, Inc.

Joint prosthesis implantation kit, reusable
Primary Device ID00885556832905
NIH Device Record Key033bac6b-a1df-4969-ad4d-874636f03301
Commercial Distribution StatusIn Commercial Distribution
Brand NameSalto Talaris Total Ankle Prosthesis
Version Model NumberMJU373T
Catalog NumberMJU373T
Company DUNS109903521
Company NameSmith & Nephew, Inc.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
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
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
GS100885556832905 [Primary]

FDA Product Code

FZXGuide, surgical, instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556832905]

Moist Heat or Steam Sterilization

[00885556832905]

Moist Heat or Steam Sterilization

[00885556832905]

Moist Heat or Steam Sterilization

[00885556832905]

Moist Heat or Steam Sterilization

[00885556832905]

Moist Heat or Steam Sterilization

[00885556832905]

Moist Heat or Steam Sterilization

[00885556832905]

Moist Heat or Steam Sterilization

[00885556832905]

Moist Heat or Steam Sterilization

[00885556832905]

Moist Heat or Steam Sterilization

[00885556832905]

Moist Heat or Steam Sterilization

[00885556832905]

Moist Heat or Steam Sterilization

[00885556832905]

Moist Heat or Steam Sterilization

[00885556832905]

Moist Heat or Steam Sterilization

[00885556832905]

Moist Heat or Steam Sterilization

[00885556832905]

Moist Heat or Steam Sterilization

[00885556832905]

Moist Heat or Steam Sterilization

[00885556832905]

Moist Heat or Steam Sterilization

[00885556832905]

Moist Heat or Steam Sterilization

[00885556832905]

Moist Heat or Steam Sterilization

[00885556832905]

Moist Heat or Steam Sterilization

[00885556832905]

Moist Heat or Steam Sterilization

[00885556832905]

Moist Heat or Steam Sterilization

[00885556832905]

Moist Heat or Steam Sterilization

[00885556832905]

Moist Heat or Steam Sterilization

[00885556832905]

Moist Heat or Steam Sterilization

[00885556832905]

Moist Heat or Steam Sterilization

[00885556832905]

Moist Heat or Steam Sterilization

[00885556832905]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-02-10
Device Publish Date2023-02-02

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
© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.