COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS

Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Cocr And Oxinium Femoral Heads And R3 Xlpe Liners.

Pre-market Notification Details

• Device ID: K093363
• 510k Number: K093363
• Device Name: COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS
• Classification: Prosthesis, Hip, Semi-constrained, Uncemented, Metal/polymer, Porous
• Applicant: SMITH & NEPHEW, INC. 1450 BROOKS ROAD Memphis, TN 38116
• Contact: Megan Bevill
• Correspondent: Megan Bevill; SMITH & NEPHEW, INC. 1450 BROOKS ROAD Memphis, TN 38116
• Product Code: MBL
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-10-28
• Decision Date: 2010-01-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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