GLOBAL TAPER SPECTRON HIP STEMS

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

SMITH & NEPHEW, INC., ORTHOPAEDIC DIV.

The following data is part of a premarket notification filed by Smith & Nephew, Inc., Orthopaedic Div. with the FDA for Global Taper Spectron Hip Stems.

Pre-market Notification Details

• Device ID: K970351
• 510k Number: K970351
• Device Name: GLOBAL TAPER SPECTRON HIP STEMS
• Classification: Prosthesis, Hip, Semi-constrained, Metal/polymer, Cemented
• Applicant: SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. 1450 BROOKS RD. Memphis, TN 38116
• Contact: Thomas L Craig
• Correspondent: Thomas L Craig; SMITH & NEPHEW, INC., ORTHOPAEDIC DIV. 1450 BROOKS RD. Memphis, TN 38116
• Product Code: JDI
• CFR Regulation Number: 888.3350 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1997-01-30
• Decision Date: 1997-02-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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