TC-PLUS / RT-PLUS 75004787

GUDID 07611996007206

TC-PLUS PATELLAR COMPONENT 26/10MM CEMENTED

Smith & Nephew, Inc.

Polyethylene patella prosthesis

• Primary Device ID: 07611996007206
• NIH Device Record Key: 3bf9e09e-f19e-4e1c-827e-c619781fb3a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TC-PLUS / RT-PLUS
• Version Model Number: 75004787
• Catalog Number: 75004787
• 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)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	07611996007206 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K000666

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: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2015-08-29

On-Brand Devices [TC-PLUS / RT-PLUS]

• 00885556008188: DRIVE ADAPTER
• 07611996117837: TC REV/RT/RT MOD. SLAP HAMMER
• 07611996080896: TC-PLUS PATELLAR DRILL WITH STOP 5.5MM
• 07611996080872: TC-PLUS SOLUTION PATELLAR CLAMP RATCHET
• 07611996031263: TC/TC-PLUS REVISION/RT/RT MODULAR PATELLAELLAR CLAMP
• 07611996024876: TC/TC REV/RT/RT MOD PATELLAR INSERTER
• 07611996024845: TC/TC REV/RT/RT MOD PAT TRIAL GUIDE 35
• 07611996024821: TC/TC REV/RT/RT MOD PAT TRIAL GUIDE 29
• 07611996024814: TC-PLUS/TC-PLUS REVISION/RT-PLUS/RT-PLUS MODULAR
• 07611996024807: TC/TC REV/RT/RT MOD PAT CLAMP BUSHING 35
• 07611996024791: TC-PLUS/TC-PLUS REVISION/RT-PLUS/RT-PLUS MODULAR
• 07611996024784: TC/TC REV/RT/RT MOD PAT CLAMP BUSHING 29
• 07611996024777: TC/TC REV/RT/RT MOD PAT CLAMP BUSHING 26
• 07611996024760: TC/TC-PLUS REVISION/RT/RT MODULAR PATELLA MILL WITH STOP 26M
• 07611996019063: TC-PLUS PATELLAR TRIAL 32/8
• 07611996019056: TC-PLUS PATELLAR TRIAL 29/8
• 07611996019049: TC-PLUS PATELLAR TRIAL 26/8
• 07611996007237: TC-PLUS PATELLAR COMPONENT 35/10MM CEMENTED
• 07611996007220: TC-PLUS PATELLAR COMPONENT 32/10MM CEM
• 07611996007213: TC-PLUS PATELLAR COMPONENT 29/10MM CEM
• 07611996007206: TC-PLUS PATELLAR COMPONENT 26/10MM CEMENTED
• 07611996007190: TC-PLUS PATELLAR COMPONENT 32/8MM CEM
• 07611996007183: TC-PLUS PATELLAR COMPONENT 29/8MM CEM
• 07611996007176: TC-PLUS PATELLAR COMPONENT 26/8MM CEM
• 03596010627582: ALLEN WRENCH 3.5MM