PROFIX 71509264

GUDID 03596010222480

PROFIX POST STAB ARTICULAR INSERT SZ 6 16MM LT

Smith & Nephew, Inc.

Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene Uncoated knee tibia prosthesis, polyethylene

• Primary Device ID: 03596010222480
• NIH Device Record Key: b5e1cf51-b5e3-4bb4-987b-f58fe28641c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PROFIX
• Version Model Number: 71509264
• Catalog Number: 71509264
• Company DUNS: 109903521
• 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)821-5700
• 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
• 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
• Phone: +1(800)238-7538
• Email: GUDID@SMITH-NEPHEW.COM

Device Identifiers

Device Issuing Agency	Device ID
GS1	03596010222480 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K954909

FDA Product Code

• JWH: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/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: 5
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-30

On-Brand Devices [PROFIX]

• 00885556732359: 3 DEGREE TIBIAL CUTTING BLOCK
• 00885556418383: PROFIX CONFORMING PLUS INSERT TRL SZ 5 RT 18MM FOR LEGION BA
• 00885556418338: PROFIX CONFORMING PLUS INSERT TRL SZ 5 RT 15MM FOR LEGION BA
• 00885556418284: PROFIX CONFORMING PLUS INSERT TRL SZ 5 RT 13MM FOR LEGION BA
• 00885556418239: PROFIX CONFORMING PLUS INSERT TRL SZ 5 RT 11MM FOR LEGION BA
• 00885556418185: PROFIX CONFORMING PLUS INSERT TRL SZ 4 RT 18MM FOR LEGION BA
• 00885556418130: PROFIX CONFORMING PLUS INSERT TRL SZ 4 RT 15MM FOR LEGION BA
• 00885556418086: PROFIX CONFORMING PLUS INSERT TRL SZ 4 RT 13MM FOR LEGION BA
• 00885556418031: PROFIX CONFORMING PLUS INSERT TRL SZ 4 RT 11MM FOR LEGION BA
• 00885556417980: PROFIX CONFORMING PLUS INSERT TRL SZ 3 RT 18MM FOR LEGION BA
• 00885556417935: PROFIX CONFORMING PLUS INSERT TRL SZ 3 RT 15MM FOR LEGION BA
• 00885556417881: PROFIX CONFORMING PLUS INSERT TRL SZ 3 RT 13MM FOR LEGION BA
• 00885556417836: PROFIX CONFORMING PLUS INSERT TRL SZ 3 RT 11MM FOR LEGION BA
• 00885556417782: PROFIX CONFORMING PLUS INSERT TRL SZ 2 RT 18MM FOR LEGION BA
• 00885556417737: PROFIX CONFORMING PLUS INSERT TRL SZ 2 RT 15MM FOR LEGION BA
• 00885556417683: PROFIX CONFORMING PLUS INSERT TRL SZ 2 RT 13MM FOR LEGION BA
• 00885556417638: PROFIX CONFORMING PLUS INSERT TRL SZ 2 RT 11MM FOR LEGION BA
• 00885556417584: PROFIX CONFORMING PLUS INSERT TRL SZ 5 LT 18MM FOR LEGION BA
• 00885556417539: PROFIX CONFORMING PLUS INSERT TRL SZ 5 LT 15MM FOR LEGION BA
• 00885556417485: PROFIX CONFORMING PLUS INSERT TRL SZ 5 LT 13MM FOR LEGION BA
• 00885556417430: PROFIX CONFORMING PLUS INSERT TRL SZ 5 LT 11MM FOR LEGION BA
• 00885556417386: PROFIX CONFORMING PLUS INSERT TRL SZ 4 LT 18MM FOR LEGION BA
• 00885556417331: PROFIX CONFORMING PLUS INSERT TRL SZ 4 LT 15MM FOR LEGION BA
• 00885556417287: PROFIX CONFORMING PLUS INSERT TRL SZ 4 LT 13MM FOR LEGION BA
• 00885556417232: PROFIX CONFORMING PLUS INSERT TRL SZ 4 LT 11MM FOR LEGION BA
• 00885556417188: PROFIX CONFORMING PLUS INSERT TRL SZ 3 LT 18MM FOR LEGION BA
• 00885556417133: PROFIX CONFORMING PLUS INSERT TRL SZ 3 LT 15MM FOR LEGION BA
• 00885556417089: PROFIX CONFORMING PLUS INSERT TRL SZ 3 LT 13MM FOR LEGION BA
• 00885556417034: PROFIX CONFORMING PLUS INSERT TRL SZ 3 LT 11MM FOR LEGION BA
• 00885556416983: PROFIX CONFORMING PLUS INSERT TRL SZ 2 LT 18MM FOR LEGION BA
• 00885556416938: PROFIX CONFORMING PLUS INSERT TRL SZ 2 LT 15MM FOR LEGION BA
• 00885556416884: PROFIX CONFORMING PLUS INSERT TRL SZ 2 LT 13MM FOR LEGION BA
• 00885556416839: PROFIX CONFORMING PLUS INSERT TRL SZ 2 LT 11MM FOR LEGION BA
• 00885556416785: PROFIX CONFORMING PLUS INSERT SZ 5 RT 18MM FOR LEGION BASEPL
• 00885556416730: PROFIX CONFORMING PLUS INSERT SZ 5 RT 15MM FOR LEGION BASEPL
• 00885556416686: PROFIX CONFORMING PLUS INSERT SZ 5 RT 13MM FOR LEGION BASEPL
• 00885556416631: PROFIX CONFORMING PLUS INSERT SZ 5 RT 11MM FOR LEGION BASEPL
• 00885556416587: PROFIX CONFORMING PLUS INSERT SZ 4 RT 18MM FOR LEGION BASEPL
• 00885556416532: PROFIX CONFORMING PLUS INSERT SZ 4 RT 15MM FOR LEGION BASEPL
• 00885556416488: PROFIX CONFORMING PLUS INSERT SZ 4 RT 13MM FOR LEGION BASEPL
• 00885556416433: PROFIX CONFORMING PLUS INSERT SZ 4 RT 11MM FOR LEGION BASEPL
• 00885556416389: PROFIX CONFORMING PLUS INSERT SZ 3 RT 18MM FOR LEGION BASEPL
• 00885556416334: PROFIX CONFORMING PLUS INSERT SZ 3 RT 15MM FOR LEGION BASEPL
• 00885556416280: PROFIX CONFORMING PLUS INSERT SZ 3 RT 13MM FOR LEGION BASEPL
• 00885556416235: PROFIX CONFORMING PLUS INSERT SZ 3 RT 11MM FOR LEGION BASEPL
• 00885556416181: PROFIX CONFORMING PLUS INSERT SZ 2 RT 18MM FOR LEGION BASEPL
• 00885556416136: PROFIX CONFORMING PLUS INSERT SZ 2 RT 15MM FOR LEGION BASEPL
• 00885556416082: PROFIX CONFORMING PLUS INSERT SZ 2 RT 13MM FOR LEGION BASEPL
• 00885556416037: PROFIX CONFORMING PLUS INSERT SZ 2 RT 11MM FOR LEGION BASEPL
• 00885556415986: PROFIX CONFORMING PLUS INSERT SZ 5 LT 18MM FOR LEGION BASEPL