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FDA 510(k)

ARTHREX PUDDU OSTEOTOMY SYSTEM

K-Number: K973812 · 1998-06-10

ApplicantArthrex, Inc.
Decision Date1998-06-10
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHREX PUDDU 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 1998-06-10 under 510(k) number K973812. 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 ARTHREX PUDDU OSTEOTOMY SYSTEM?

ARTHREX PUDDU OSTEOTOMY SYSTEM is a medical device that received FDA 510(k) clearance on 1998-06-10. The listed applicant is Arthrex, Inc.. The 510(k) number is K973812.

When did ARTHREX PUDDU OSTEOTOMY SYSTEM receive FDA 510(k) clearance?

ARTHREX PUDDU OSTEOTOMY SYSTEM received FDA 510(k) clearance on 1998-06-10, under 510(k) number K973812.

Who is the listed applicant for ARTHREX PUDDU 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 ARTHREX PUDDU OSTEOTOMY SYSTEM?

The FDA product code for ARTHREX PUDDU OSTEOTOMY SYSTEM 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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