K-15 PORK 71425328

GUDID 00885556733097

POROUS TIBIA BASEPLATE W/JRNY LOCK SZ 8 LEFT

Smith & Nephew, Inc.

Uncoated knee tibia prosthesis, metallic

• Primary Device ID: 00885556733097
• NIH Device Record Key: d4839247-07e3-4ade-bacd-5a9e1b693ad4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: K-15 PORK
• Version Model Number: 71425328
• Catalog Number: 71425328
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00885556733097 [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: 2021-10-15
• Device Publish Date: 2021-10-07

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