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FDA 510(k)

OPENING/CLOSING WEDGE OSTETOMY PLATES

K-Number: K014155 · 2002-03-18

ApplicantArthrex, Inc.
Decision Date2002-03-18
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OPENING/CLOSING WEDGE OSTETOMY PLATES is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2002-03-18 under 510(k) number K014155. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPENING/CLOSING WEDGE OSTETOMY PLATES?

OPENING/CLOSING WEDGE OSTETOMY PLATES is a medical device that received FDA 510(k) clearance on 2002-03-18. The listed applicant is Arthrex, Inc.. The 510(k) number is K014155.

When did OPENING/CLOSING WEDGE OSTETOMY PLATES receive FDA 510(k) clearance?

OPENING/CLOSING WEDGE OSTETOMY PLATES received FDA 510(k) clearance on 2002-03-18, under 510(k) number K014155.

Who is the listed applicant for OPENING/CLOSING WEDGE OSTETOMY PLATES?

The FDA 510(k) record lists Arthrex, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OPENING/CLOSING WEDGE OSTETOMY PLATES?

The FDA product code for OPENING/CLOSING WEDGE OSTETOMY PLATES is HRS.

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Related Devices (Code: HRS)

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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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