FDA 510(k)

GLOBAL TAPER SPECTRON HIP STEMS

K-Number: K970351 · 1997-02-28

ApplicantSmith & Nephew, Inc., Orthopaedic Div.

Decision Date1997-02-28

Product CodeJDI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

GLOBAL TAPER SPECTRON HIP STEMS is the device name listed in this FDA 510(k) record. The listed applicant is Smith & Nephew, Inc., Orthopaedic Div.. It received FDA 510(k) clearance on 1997-02-28 under 510(k) number K970351. The device is classified under product code JDI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GLOBAL TAPER SPECTRON HIP STEMS?

GLOBAL TAPER SPECTRON HIP STEMS is a medical device that received FDA 510(k) clearance on 1997-02-28. The listed applicant is Smith & Nephew, Inc., Orthopaedic Div.. The 510(k) number is K970351.

When did GLOBAL TAPER SPECTRON HIP STEMS receive FDA 510(k) clearance?

GLOBAL TAPER SPECTRON HIP STEMS received FDA 510(k) clearance on 1997-02-28, under 510(k) number K970351.

Who is the listed applicant for GLOBAL TAPER SPECTRON HIP STEMS?

The FDA 510(k) record lists Smith & Nephew, Inc., Orthopaedic Div. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLOBAL TAPER SPECTRON HIP STEMS?

The FDA product code for GLOBAL TAPER SPECTRON HIP STEMS is JDI.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.