K15-PORK 71434645

GUDID 00885556721919

POROUS TIBIA BASEPLATE TRIAL SZ 1 RIGHT

Smith & Nephew, Inc.

Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic Uncoated knee tibia prosthesis, metallic

• Primary Device ID: 00885556721919
• NIH Device Record Key: 12fcab47-0e13-42fa-9b1e-b4284011ca33
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K15-PORK
• Version Model Number: 71434645
• Catalog Number: 71434645
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556721919 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211221

FDA Product Code

• MBH: PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[00885556721919]

Moist Heat or Steam Sterilization

[00885556721919]

Moist Heat or Steam Sterilization

[00885556721919]

Moist Heat or Steam Sterilization

[00885556721919]

Moist Heat or Steam Sterilization

[00885556721919]

Moist Heat or Steam Sterilization

[00885556721919]

Moist Heat or Steam Sterilization

[00885556721919]

Moist Heat or Steam Sterilization

[00885556721919]

Moist Heat or Steam Sterilization

[00885556721919]

Moist Heat or Steam Sterilization

[00885556721919]

Moist Heat or Steam Sterilization

[00885556721919]

Moist Heat or Steam Sterilization

[00885556721919]

Moist Heat or Steam Sterilization

[00885556721919]

Moist Heat or Steam Sterilization

[00885556721919]

Moist Heat or Steam Sterilization

[00885556721919]

Moist Heat or Steam Sterilization

[00885556721919]

Moist Heat or Steam Sterilization

[00885556721919]

Moist Heat or Steam Sterilization

[00885556721919]

Moist Heat or Steam Sterilization

[00885556721919]

Moist Heat or Steam Sterilization

[00885556721919]

Moist Heat or Steam Sterilization

[00885556721919]

Moist Heat or Steam Sterilization

[00885556721919]

Moist Heat or Steam Sterilization

[00885556721919]

Moist Heat or Steam Sterilization

[00885556721919]

Moist Heat or Steam Sterilization

[00885556721919]

Moist Heat or Steam Sterilization

[00885556721919]

Moist Heat or Steam Sterilization

[00885556721919]

Moist Heat or Steam Sterilization

[00885556721919]

Moist Heat or Steam Sterilization

[00885556721919]

Moist Heat or Steam Sterilization

[00885556721919]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-19
• Device Publish Date: 2021-10-11

On-Brand Devices [K15-PORK]

• 00885556744635: POROUS TIBIA DRILL
• 00885556744628: POROUS TIBIA PUNCH
• 00885556744567: POROUS TIBIA FIN PUNCH GUIDE SZ 5-6
• 00885556744550: POROUS TIBIA FIN PUNCH GUIDE SZ 3-4
• 00885556744543: POROUS TIBIA FIN PUNCH GUIDE SZ 1-2
• 00885556722022: POROUS TIBIA FIN PUNCH SZ 7-8
• 00885556722015: POROUS TIBIA FIN PUNCH SZ 5-6
• 00885556722008: POROUS TIBIA FIN PUNCH SZ 3-4
• 00885556721995: POROUS TIBIA FIN PUNCH SZ 1-2
• 00885556722572: POROUS TIBIA BASEPLATE TRIAL SZ 1 LEFT
• 00885556721988: POROUS TIBIA BASEPLATE TRIAL SZ 8 RIGHT
• 00885556721971: POROUS TIBIA BASEPLATE TRIAL SZ 7 RIGHT
• 00885556721964: POROUS TIBIA BASEPLATE TRIAL SZ 6 RIGHT
• 00885556721957: POROUS TIBIA BASEPLATE TRIAL SZ 5 RIGHT
• 00885556721940: POROUS TIBIA BASEPLATE TRIAL SZ 4 RIGHT
• 00885556721933: POROUS TIBIA BASEPLATE TRIAL SZ 3 RIGHT
• 00885556721926: POROUS TIBIA BASEPLATE TRIAL SZ 2 RIGHT
• 00885556721919: POROUS TIBIA BASEPLATE TRIAL SZ 1 RIGHT
• 00885556721902: POROUS TIBIA BASEPLATE TRIAL SZ 8 LEFT
• 00885556721896: POROUS TIBIA BASEPLATE TRIAL SZ 7 LEFT
• 00885556721889: POROUS TIBIA BASEPLATE TRIAL SZ 6 LEFT
• 00885556721872: POROUS TIBIA BASEPLATE TRIAL SZ 5 LEFT
• 00885556721858: POROUS TIBIA BASEPLATE TRIAL SZ 3 LEFT
• 00885556721841: POROUS TIBIA BASEPLATE TRIAL SZ 2 LEFT