ANTHOLOGY HIP STEM

Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented

SMITH & NEPHEW, INC.

The following data is part of a premarket notification filed by Smith & Nephew, Inc. with the FDA for Anthology Hip Stem.

Pre-market Notification Details

• Device ID: K052792
• 510k Number: K052792
• Device Name: ANTHOLOGY HIP STEM
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
• Applicant: SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Contact: Janet Akil
• Correspondent: Janet Akil; SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Product Code: JDI
• Subsequent Product Code: LPH
• Subsequent Product Code: LZO
• Subsequent Product Code: MEH
• CFR Regulation Number: 888.3350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-10-03
• Decision Date: 2005-10-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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