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FDA 510(k)

COMPASS UNIVERSAL HINGE

K-Number: K970713 · 1997-04-03

ApplicantSmith & Nephew, Inc., Orthopaedic Div.
Decision Date1997-04-03
Product CodeJDW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COMPASS UNIVERSAL HINGE 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 1997-04-03 under 510(k) number K970713. The device is classified under product code JDW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPASS UNIVERSAL HINGE?

COMPASS UNIVERSAL HINGE is a medical device that received FDA 510(k) clearance on 1997-04-03. The listed applicant is Smith & Nephew, Inc., Orthopaedic Div.. The 510(k) number is K970713.

When did COMPASS UNIVERSAL HINGE receive FDA 510(k) clearance?

COMPASS UNIVERSAL HINGE received FDA 510(k) clearance on 1997-04-03, under 510(k) number K970713.

Who is the listed applicant for COMPASS UNIVERSAL HINGE?

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 COMPASS UNIVERSAL HINGE?

The FDA product code for COMPASS UNIVERSAL HINGE is JDW.

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Other records listing Smith & Nephew, Inc., Orthopaedic Div. as applicant

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Related Devices (Code: JDW)

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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.

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