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FDA 510(k)

ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM

K-Number: K032187 · 2003-09-22

ApplicantArthrex, Inc.
Decision Date2003-09-22
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2003-09-22 under 510(k) number K032187. 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 ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM?

ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM is a medical device that received FDA 510(k) clearance on 2003-09-22. The listed applicant is Arthrex, Inc.. The 510(k) number is K032187.

When did ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM receive FDA 510(k) clearance?

ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM received FDA 510(k) clearance on 2003-09-22, under 510(k) number K032187.

Who is the listed applicant for ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM?

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 ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM?

The FDA product code for ANTHREX TITANIUM OPENING WEDGE OSTEOTOMY SYSTEM is 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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