K-15 PORK 74027435

GUDID 00885556769843

POROUS OVAL PATELLA SZ 35MM

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

• Primary Device ID: 00885556769843
• NIH Device Record Key: 74c3d160-e9c0-45e3-9f30-d7af878b5ac0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-15 PORK
• Version Model Number: 74027435
• Catalog Number: 74027435
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556769843 [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: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-10-18
• Device Publish Date: 2021-10-08

On-Brand Devices [K-15 PORK]

• 00885556744574: POROUS TIBIA FIN PUNCH GUIDE SZ 7-8
• 00885556769867: POROUS OVAL PATELLA SZ 41MM
• 00885556769850: POROUS OVAL PATELLA SZ 38MM
• 00885556769836: POROUS OVAL PATELLA SZ 32MM
• 00885556769829: POROUS OVAL PATELLA SZ 29MM
• 00885556733097: POROUS TIBIA BASEPLATE W/JRNY LOCK SZ 8 LEFT
• 00885556733080: POROUS TIBIA BASEPLATE W/JRNY LOCK SZ 7 LEFT
• 00885556733073: POROUS TIBIA BASEPLATE W/JRNY LOCK SZ 6 LEFT
• 00885556733066: POROUS TIBIA BASEPLATE W/JRNY LOCK SZ 5 LEFT
• 00885556733059: POROUS TIBIA BASEPLATE W/JRNY LOCK SZ 4 LEFT
• 00885556733042: POROUS TIBIA BASEPLATE W/JRNY LOCK SZ 3 LEFT
• 00885556733035: POROUS TIBIA BASEPLATE W/JRNY LOCK SZ 2 LEFT
• 00885556733028: POROUS TIBIA BASEPLATE W/ JRNY LOCK SZ 1 LEFT
• 00885556733011: POROUS TIBIA BASEPLATE W/JRNY LOCK SZ 8 RIGHT
• 00885556733004: POROUS TIBIA BASEPLATE W/JRNY LOCK SZ 7 RIGHT
• 00885556732991: POROUS TIBIA BASEPLATE W/JRNY LOCK SZ 6 RIGHT
• 00885556732984: POROUS TIBIA BASEPLATE W/JRNY LOCK SZ 5 RIGHT
• 00885556732977: POROUS TIBIA BASEPLATE W/JRNY LOCK SZ 4 RIGHT
• 00885556732960: POROUS TIBIA BASEPLATE W/JRNY LOCK SZ 3 RIGHT
• 00885556732953: POROUS TIBIA BASEPLATE W/JRNY LOCK SZ 2 RIGHT
• 00885556769843: POROUS OVAL PATELLA SZ 35MM