XT Revision Ankle Replacement System MJU938T

GUDID 00885556841495

INTEGRA XT. PUNCHING TIP

Smith & Nephew, Inc.

Joint prosthesis implantation kit, reusable
Primary Device ID00885556841495
NIH Device Record Keyb04d0e71-7238-4384-883e-5baee6e417aa
Commercial Distribution StatusIn Commercial Distribution
Brand NameXT Revision Ankle Replacement System
Version Model NumberMJU938T
Catalog NumberMJU938T
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
GS100885556841495 [Primary]

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00885556841495]

Moist Heat or Steam Sterilization

[00885556841495]

Moist Heat or Steam Sterilization

[00885556841495]

Moist Heat or Steam Sterilization

[00885556841495]

Moist Heat or Steam Sterilization

[00885556841495]

Moist Heat or Steam Sterilization

[00885556841495]

Moist Heat or Steam Sterilization

[00885556841495]

Moist Heat or Steam Sterilization

[00885556841495]

Moist Heat or Steam Sterilization

[00885556841495]

Moist Heat or Steam Sterilization

[00885556841495]

Moist Heat or Steam Sterilization

[00885556841495]

Moist Heat or Steam Sterilization

[00885556841495]

Moist Heat or Steam Sterilization

[00885556841495]

Moist Heat or Steam Sterilization

[00885556841495]

Moist Heat or Steam Sterilization

[00885556841495]

Moist Heat or Steam Sterilization

[00885556841495]

Moist Heat or Steam Sterilization

[00885556841495]

Moist Heat or Steam Sterilization

[00885556841495]

Moist Heat or Steam Sterilization

[00885556841495]

Moist Heat or Steam Sterilization

[00885556841495]

Moist Heat or Steam Sterilization

[00885556841495]

Moist Heat or Steam Sterilization

[00885556841495]

Moist Heat or Steam Sterilization

[00885556841495]

Moist Heat or Steam Sterilization

[00885556841495]

Moist Heat or Steam Sterilization

[00885556841495]

Moist Heat or Steam Sterilization

[00885556841495]

Moist Heat or Steam Sterilization

[00885556841495]

Moist Heat or Steam Sterilization

[00885556841495]

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 [XT Revision Ankle Replacement System]

00885556842164TIBIAL ALIGNMENT GUIDE. NO BLOCK
008855568421577 DEGREE BLOCK. TIBIAL ALIGNMENT
00885556841761INTEGRA XT. TIBIAL TRIAL JIG. SIZE 3. THICK
00885556841754INTEGRA XT. TIBIAL TRIAL JIG. SIZE 2. THICK
00885556841747INTEGRA XT. TIBIAL TRIAL JIG. SIZE 1. THICK
00885556841730INTEGRA XT. TIBIAL TRIAL JIG. SIZE 0. THICK
00885556841723INTEGRA XT. TIBIAL TRIAL JIG. SIZE 3
00885556841716INTEGRA XT. TIBIAL TRIAL JIG. SIZE 2
00885556841709INTEGRA XT. TIBIAL TRIAL JIG. SIZE 1
00885556841693INTEGRA XT. TIBIAL TRIAL JIG. SIZE 0
00885556841686INTEGRA XT. TIBIAL TRIAL RASP. SIZE 3
00885556841679INTEGRA XT. TIBIAL TRIAL RASP SIZE 2
00885556841662INTEGRA XT. TIBIAL TRIAL RASP. SIZE 1
00885556841655INTEGRA XT. TIBIAL TRIAL RASP. SIZE 0
00885556841648INTEGRA XT. SLOPED TALAR CUTTING GUIDE
00885556841624INTEGRA XT. DRILL 4.5 MM
00885556841600INTEGRA XT. SLOPED TALAR TRIAL. SIZE 3. LEFT
00885556841594INTEGRA XT. SLOPED TALAR TRIAL. SIZE 2. LEFT
00885556841587INTEGRA XT. SLOPED TALAR TRIAL. SIZE 1. LEFT
00885556841570INTEGRA XT. SLOPED TALAR TRIAL. SIZE 0. LEFT
00885556841563INTEGRA XT. SLOPED TALAR TRIAL. SIZE 3. RIGHT
00885556841556INTEGRA XT. SLOPED TALAR TRIAL. SIZE 2. RIGHT
00885556841549INTEGRA XT. SLOPED TALAR TRIAL. SIZE 1. RIGHT
00885556841532INTEGRA XT. SLOPED TALAR TRIAL. SIZE 0. RIGHT
00885556841518INTEGRA XT. IN SITU POLY INSERTER
00885556841501INTEGRA XT. DRILL. TAPERED
00885556841495INTEGRA XT. PUNCHING TIP
00885556841471INTEGRA XT. TIBIAL HOLDER
00885556841464INTEGRA XT. JOINT DISTRACTOR. LEFT
00885556841457INTEGRA XT. JOINT DISTRACTOR. RIGHT
00885556841440INTEGRA XT. TIBIAL OSTEOTOME
00885556842171INTEGRA XT. ATTACHMENT SCREW
00885556842140INTEGRA XT. TRIAL INSERT. SIZE 00. LEFT. TH21
00885556842133INTEGRA XT. TRIAL INSERT. SIZE 00. LEFT. TH19
00885556842126INTEGRA XT. TRIAL INSERT. SIZE 00. RIGHT. TH21
00885556842119INTEGRA XT. TRIAL INSERT. SIZE 00. RIGHT. TH19
00885556842102INTEGRA XT. TRIAL INSERT. SIZE 01. LEFT. TH21
00885556842096INTEGRA XT. TRIAL INSERT. SIZE 01. LEFT. TH19
00885556842089INTEGRA XT. TRIAL INSERT. SIZE 01. LEFT. TH17
00885556842072INTEGRA XT. TRIAL INSERT. SIZE 01. LEFT. TH15
00885556842065INTEGRA XT. TRIAL INSERT. SIZE 01. LEFT. TH13
00885556842058INTEGRA XT. TRIAL INSERT. SIZE 01. LEFT. TH11
00885556842041INTEGRA XT. TRIAL INSERT. SIZE 01. LEFT. TH10
00885556842034INTEGRA XT. TRIAL INSERT. SIZE 01. LEFT. TH9
00885556842027INTEGRA XT. TRIAL INSERT. SIZE 01. LEFT. TH8
00885556842010INTEGRA XT. TRIAL INSERT. SIZE 01. RIGHT. TH21
00885556842003INTEGRA XT. TRIAL INSERT. SIZE 01. RIGHT. TH19
00885556841990INTEGRA XT. TRIAL INSERT. SIZE 01. RIGHT. TH17
00885556841983INTEGRA XT. TRIAL INSERT. SIZE 01. RIGHT. TH15
00885556841976INTEGRA XT. TRIAL INSERT. SIZE 01. RIGHT. TH13
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