ECHELON HIP STEM

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

SMITH & NEPHEW, INC.

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

Pre-market Notification Details

• Device ID: K983834
• 510k Number: K983834
• Device Name: ECHELON HIP STEM
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented
• Applicant: SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Contact: Joann Kuhne
• Correspondent: Joann Kuhne; SMITH & NEPHEW, INC. 1450 BROOKS RD. Memphis, TN 38116
• Product Code: LPH
• CFR Regulation Number: 888.3358 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Abbreviated
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1998-10-30
• Decision Date: 1999-02-24
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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