TC-PLUS / RT-PLUS 75004790

GUDID 07611996007237

TC-PLUS PATELLAR COMPONENT 35/10MM CEMENTED

Smith & Nephew, Inc.

Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis Polyethylene patella prosthesis

• Primary Device ID: 07611996007237
• NIH Device Record Key: cde72678-4c3e-439f-a45a-df660188e9fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TC-PLUS / RT-PLUS
• Version Model Number: 75004790
• Catalog Number: 75004790
• 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	07611996007237 [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