SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS

Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Smith & Nephew Global Femoral Head Trials.

Pre-market Notification Details

• Device ID: K132435
• 510k Number: K132435
• Device Name: SMITH & NEPHEW GLOBAL FEMORAL HEAD TRIALS
• Classification: Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented
• Applicant: SMITH & NEPHEW, INC. 7135 Goodlett Farms Parkway Cordova, TN 38016
• Contact: Megan Fessenden
• Correspondent: Megan Fessenden; SMITH & NEPHEW, INC. 7135 Goodlett Farms Parkway Cordova, TN 38016
• Product Code: LZO
• Subsequent Product Code: JDI
• Subsequent Product Code: KWY
• Subsequent Product Code: LPH
• Subsequent Product Code: LWJ
• Subsequent Product Code: MBL
• Subsequent Product Code: MEH
• CFR Regulation Number: 888.3353 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2013-08-05
• Decision Date: 2013-10-22
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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07611996122091	K132435	000