XT Revision Ankle Replacement System LJV161T

GUDID 00885556841068

INTEGRA XT. TIBIAL TRAY. SIZE 1. TH4

Smith & Nephew, Inc.

Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis Fixed-bearing total ankle prosthesis

• Primary Device ID: 00885556841068
• NIH Device Record Key: b8fcd0d0-56fb-4ba9-ad6b-6fb4bb273d67
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: XT Revision Ankle Replacement System
• Version Model Number: LJV161T
• Catalog Number: LJV161T
• 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	00885556841068 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153452

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 [XT Revision Ankle Replacement System]

• 00885556842164: TIBIAL ALIGNMENT GUIDE. NO BLOCK
• 00885556842157: 7 DEGREE BLOCK. TIBIAL ALIGNMENT
• 00885556841761: INTEGRA XT. TIBIAL TRIAL JIG. SIZE 3. THICK
• 00885556841754: INTEGRA XT. TIBIAL TRIAL JIG. SIZE 2. THICK
• 00885556841747: INTEGRA XT. TIBIAL TRIAL JIG. SIZE 1. THICK
• 00885556841730: INTEGRA XT. TIBIAL TRIAL JIG. SIZE 0. THICK
• 00885556841723: INTEGRA XT. TIBIAL TRIAL JIG. SIZE 3
• 00885556841716: INTEGRA XT. TIBIAL TRIAL JIG. SIZE 2
• 00885556841709: INTEGRA XT. TIBIAL TRIAL JIG. SIZE 1
• 00885556841693: INTEGRA XT. TIBIAL TRIAL JIG. SIZE 0
• 00885556841686: INTEGRA XT. TIBIAL TRIAL RASP. SIZE 3
• 00885556841679: INTEGRA XT. TIBIAL TRIAL RASP SIZE 2
• 00885556841662: INTEGRA XT. TIBIAL TRIAL RASP. SIZE 1
• 00885556841655: INTEGRA XT. TIBIAL TRIAL RASP. SIZE 0
• 00885556841648: INTEGRA XT. SLOPED TALAR CUTTING GUIDE
• 00885556841624: INTEGRA XT. DRILL 4.5 MM
• 00885556841600: INTEGRA XT. SLOPED TALAR TRIAL. SIZE 3. LEFT
• 00885556841594: INTEGRA XT. SLOPED TALAR TRIAL. SIZE 2. LEFT
• 00885556841587: INTEGRA XT. SLOPED TALAR TRIAL. SIZE 1. LEFT
• 00885556841570: INTEGRA XT. SLOPED TALAR TRIAL. SIZE 0. LEFT
• 00885556841563: INTEGRA XT. SLOPED TALAR TRIAL. SIZE 3. RIGHT
• 00885556841556: INTEGRA XT. SLOPED TALAR TRIAL. SIZE 2. RIGHT
• 00885556841549: INTEGRA XT. SLOPED TALAR TRIAL. SIZE 1. RIGHT
• 00885556841532: INTEGRA XT. SLOPED TALAR TRIAL. SIZE 0. RIGHT
• 00885556841518: INTEGRA XT. IN SITU POLY INSERTER
• 00885556841501: INTEGRA XT. DRILL. TAPERED
• 00885556841495: INTEGRA XT. PUNCHING TIP
• 00885556841471: INTEGRA XT. TIBIAL HOLDER
• 00885556841464: INTEGRA XT. JOINT DISTRACTOR. LEFT
• 00885556841457: INTEGRA XT. JOINT DISTRACTOR. RIGHT
• 00885556841440: INTEGRA XT. TIBIAL OSTEOTOME
• 00885556842171: INTEGRA XT. ATTACHMENT SCREW
• 00885556842140: INTEGRA XT. TRIAL INSERT. SIZE 00. LEFT. TH21
• 00885556842133: INTEGRA XT. TRIAL INSERT. SIZE 00. LEFT. TH19
• 00885556842126: INTEGRA XT. TRIAL INSERT. SIZE 00. RIGHT. TH21
• 00885556842119: INTEGRA XT. TRIAL INSERT. SIZE 00. RIGHT. TH19
• 00885556842102: INTEGRA XT. TRIAL INSERT. SIZE 01. LEFT. TH21
• 00885556842096: INTEGRA XT. TRIAL INSERT. SIZE 01. LEFT. TH19
• 00885556842089: INTEGRA XT. TRIAL INSERT. SIZE 01. LEFT. TH17
• 00885556842072: INTEGRA XT. TRIAL INSERT. SIZE 01. LEFT. TH15
• 00885556842065: INTEGRA XT. TRIAL INSERT. SIZE 01. LEFT. TH13
• 00885556842058: INTEGRA XT. TRIAL INSERT. SIZE 01. LEFT. TH11
• 00885556842041: INTEGRA XT. TRIAL INSERT. SIZE 01. LEFT. TH10
• 00885556842034: INTEGRA XT. TRIAL INSERT. SIZE 01. LEFT. TH9
• 00885556842027: INTEGRA XT. TRIAL INSERT. SIZE 01. LEFT. TH8
• 00885556842010: INTEGRA XT. TRIAL INSERT. SIZE 01. RIGHT. TH21
• 00885556842003: INTEGRA XT. TRIAL INSERT. SIZE 01. RIGHT. TH19
• 00885556841990: INTEGRA XT. TRIAL INSERT. SIZE 01. RIGHT. TH17
• 00885556841983: INTEGRA XT. TRIAL INSERT. SIZE 01. RIGHT. TH15
• 00885556841976: INTEGRA XT. TRIAL INSERT. SIZE 01. RIGHT. TH13