TC-PLUS Primary 75000335

GUDID 07611996094145

TC PRIM FIXED TIB INSERT VKS CS LT 6/20

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

• Primary Device ID: 07611996094145
• NIH Device Record Key: 0e23b53a-daac-418c-9b79-8a81e55ad420
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TC-PLUS Primary
• Version Model Number: 75000335
• Catalog Number: 75000335
• 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)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com
• Phone: +1(800)821-5700
• Email: gudid@smith-nephew.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07611996094145 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K072858

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: 4
• Public Version Date: 2020-01-31
• Device Publish Date: 2015-08-29

On-Brand Devices [TC-PLUS Primary]

• 07611996105445: TC PRIM FIXED TIB INSERT VKS CR RT 0/20
• 07611996094640: TC PRIM FIXED TIB INSERT VKS CS RT 12/20
• 07611996094633: TC PRIM FIXED TIB INSERT VKS CS RT 12/17
• 07611996094626: TC PRIM FIXED TIB INSERT VKS CS RT 12/14
• 07611996094619: TC PRIM FIXED TIB INSERT VKS CS RT 12/12
• 07611996094602: TC PRIM FIXED TIB INSERT VKS CS RT 12/10
• 07611996094596: TC PRIM FIXED TIB INSERT VKS CS RT10/20
• 07611996094589: TC PRIM FIXED TIB INSERT VKS CS RT 10/17
• 07611996094572: TC PRIM FIXED TIB INSERT VKS CS RT 10/14
• 07611996094565: TC PRIM FIXED TIB INSERT VKS CS RT 10/12
• 07611996094558: TC PRIM FIXED TIB INSERT VKS CS RT 10/10
• 07611996094541: TC PRIM FIXED TIB INSERT VKS CS RT 8/20
• 07611996094534: TC PRIM FIXED TIB INSERT VKS CS RT 8/17
• 07611996094527: TC PRIM FIXED TIB INSERT VKS CS RT 8/14
• 07611996094510: TC PRIM FIXED TIB INSERT VKS CS RT 8/12
• 07611996094503: TC PRIM FIXED TIB INSERT VKS CS RT 8/10
• 07611996094497: TC PRIM FIXED TIB INSERT VKS CS RT 6/20
• 07611996094480: TC PRIM FIXED TIB INSERT VKS CS RT 6/17
• 07611996094473: TC PRIM FIXED TIB INSERT VKS CS RT 6/14
• 07611996094466: TC PRIM FIXED TIB INSERT VKS CS RT 6/12
• 07611996094459: TC PRIM FIXED TIB INSERT VKS CS RT 6/10
• 07611996094442: TC PRIM FIXED TIB INSERT VKS CS RT 4/20
• 07611996094435: TC PRIM FIXED TIB INSERT VKS CS RT 4/17
• 07611996094428: TC PRIM FIXED TIB INSERT VKS CS RT 4/14
• 07611996094411: TC PRIM FIXED TIB INSERT VKS CS RT 4/12
• 07611996094404: TC PRIM FIXED TIB INSERT VKS CS RT 4/10
• 07611996094398: TC PRIM FIXED TIB INSERT VKS CS RT 2/20
• 07611996094381: TC PRIM FIXED TIB INSERT VKS CS RT 2/17
• 07611996094374: TC PRIM FIXED TIB INSERT VKS CS RT 2/14
• 07611996094367: TC PRIM FIXED TIB INSERT VKS CS RT 2/12
• 07611996094350: TC PRIM FIXED TIB INSERT VKS CS RT 2/10
• 07611996094299: TC PRIM FIXED TIB INSERT VKS CS LT 12/20
• 07611996094282: TC PRIM FIXED TIB INSERT VKS CS LT 12/17
• 07611996094275: TC PRIM FIXED TIB INSERT VKS CS LT 12/14
• 07611996094268: TC PRIM FIXED TIB INSERT VKS CS LT 12/12
• 07611996094251: TC PRIM FIXED TIB INSERT VKS CS LT 12/10
• 07611996094244: TC PRIM FIXED TIB INSERT VKS CS LT 10/20
• 07611996094237: TC PRIM FIXED TIB INSERT VKS CS LT 10/17
• 07611996094220: TC PRIM FIXED TIB INSERT VKS CS LT 10/14
• 07611996094213: TC PRIM FIXED TIB INSERT VKS CS LT 10/12
• 07611996094206: TC PRIM FIXED TIB INSERT VKS CS LT 10/10
• 07611996094190: TC PRIM FIXED TIB INSERT VKS CS LT 8/20
• 07611996094183: TC PRIM FIXED TIB INSERT VKS CS LT 8/17
• 07611996094176: TC PRIM FIXED TIB INSERT VKS CS LT 8/14
• 07611996094169: TC PRIM FIXED TIB INSERT VKS CS LT 8/12
• 07611996094152: TC PRIM FIXED TIB INSERT VKS CS LT 8/10
• 07611996094145: TC PRIM FIXED TIB INSERT VKS CS LT 6/20
• 07611996094138: TC PRIM FIXED TIB INSERT VKS CS LT 6/17
• 07611996094121: TC PRIM FIXED TIB INSERT VKS CS LT 6/14
• 07611996094114: TC PRIM FIXED TIB INSERT VKS CS LT 6/12