TC-PLUS Primary 75000321

GUDID 07611996094008

TC PRIM FIXED TIB INSERT VKS CS LT 2/10

Smith & Nephew, Inc.

Uncoated knee tibia prosthesis, polyethylene

• Primary Device ID: 07611996094008
• NIH Device Record Key: 9117409e-f2e6-4a96-97d5-2c64b13e535e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TC-PLUS Primary
• Version Model Number: 75000321
• Catalog Number: 75000321
• 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
• 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	07611996094008 [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