SMITH & NEPHEW RADIOPAQUE TRIAL NECKS

Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Radiopaque Trial Necks.

Pre-market Notification Details

• Device ID: K113039
• 510k Number: K113039
• Device Name: SMITH & NEPHEW RADIOPAQUE TRIAL NECKS
• Classification: Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
• Applicant: SMITH & NEPHEW, INC. 7135 Goodlett Farms Parkway Cordova, TN 38016
• Contact: Natalie P Williams
• Correspondent: Natalie P Williams; SMITH & NEPHEW, INC. 7135 Goodlett Farms Parkway Cordova, TN 38016
• Product Code: MEH
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-10-12
• Decision Date: 2012-10-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00885556338247	K113039	000
00885556223840	K113039	000
00885556104163	K113039	000
00885556104118	K113039	000
00885556104019	K113039	000