TC-PLUS 75005217

GUDID 07611996073928

TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC PS 12/17

Smith & Nephew, Inc.

Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert Tibial insert

• Primary Device ID: 07611996073928
• NIH Device Record Key: a3dc0c50-f780-4f7d-898b-84b6c87660a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TC-PLUS
• Version Model Number: 75005217
• Catalog Number: 75005217
• Company DUNS: 045483575
• 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: false
• 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: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	07611996073928 [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: 2023-09-07
• Device Publish Date: 2022-12-12

On-Brand Devices [TC-PLUS]

• 07611996102079: TC-PLUS PRIMARY TIBIAL STYLUS ADJUSTABLE
• 07611996086614: TIBIA V/V CUT GUIDE RIGHT 1.27
• 07611996086607: TIBIA V/V CUT GUIDE LEFT 1.27
• 07611996077759: TC-PLUS PRIMARY MIS/TC-PLUS PRIMARY TIBIAL STYLUS
• 07611996036596: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC CS ULTRA
• 07611996033687: PLUSTC SB SOLU TIBL STYLUS ADJ
• 07611996031270: PLUSTC SOLU PAT CUT GDE
• 07611996029437: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC CS ULTRA
• 07611996024531: TC-PLUS SOLUTION TIBIAL STYLUS
• 07611996024524: PLUSTC SOLU TIBL CUT BLOCK
• 07611996009415: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC CS ULTRA
• 07611996009392: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC CS ULTRA
• 07611996009378: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC CS ULTRA
• 07611996009361: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC CS ULTRA
• 07611996009347: TC PRIM/TC REV TIB INS TC CS ULTRAC10/13
• 07611996009330: TC PRIM/TC REV TIB INS TC CS ULTRAC10/11
• 07611996009323: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC CS ULTRA
• 07611996009316: TC PRIM/TC REV TIB INS TC CS ULTRAC 8/19
• 07611996009293: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC CS ULTRA
• 07611996009286: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC CS ULTRA
• 07611996009279: TC PRIM/TC REV TIB INS TC CS ULTRAC 8/9
• 07611996009262: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC CS ULTRA
• 07611996009248: TC PRIM/TC REV TIB INS TC CS ULTRAC 6/13
• 07611996009231: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC CS ULTRA
• 07611996009224: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC CS ULTRA
• 07611996009217: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC CS ULTRA
• 07611996009194: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC CS ULTRA
• 07611996009187: TC PRIM/TC REV TIB INS TC CS ULTRAC 4/11
• 07611996009170: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC CS ULTRA
• 07611996009163: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC CS ULTRA
• 07611996009149: TC PRIM/TC REV TIB INS TC CS ULTRAC 2/13
• 07611996009132: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC CS ULTRA
• 07611996009125: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC CS ULTRA
• 07611996009064: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC CS ULTRA
• 07611996009057: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC CS ULTRA
• 07611996009040: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC CS ULTRA
• 07611996009033: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC CS ULTRA
• 07611996009026: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC CS ULTRA
• 07611996009019: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC CS ULTRA
• 07611996008708: TC-PLUS PRIMARY TIBIAL INSERT TC CR 6/11
• 07611996073935: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC PS 12/19
• 07611996073928: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC PS 12/17
• 07611996073911: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC PS 12/15
• 07611996073904: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC PS 12/13
• 07611996073898: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC PS 12/11
• 07611996073881: TC-PLUS PRIMARY / TC-PLUS REVISION TIBIAL INSERT TC PS 12/9
• 07611996073867: TC PRIM/TC REV TIB INSERT TC PS 10/21
• 07611996073850: TC PRIM/TC REV TIB INSERT TC PS 10/19
• 07611996073843: TC PRIM/TC REV TIB INSERT TC PS 10/17
• 07611996073836: TC PRIM/TC REV TIB INSERT TC PS 10/15