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FDA 510(k)

ARTHREX CROSSPIN, MODEL AR-1964P

K-Number: K063719 · 2007-03-06

ApplicantArthrex, Inc.
Decision Date2007-03-06
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHREX CROSSPIN, MODEL AR-1964P is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2007-03-06 under 510(k) number K063719. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTHREX CROSSPIN, MODEL AR-1964P?

ARTHREX CROSSPIN, MODEL AR-1964P is a medical device that received FDA 510(k) clearance on 2007-03-06. The listed applicant is Arthrex, Inc.. The 510(k) number is K063719.

When did ARTHREX CROSSPIN, MODEL AR-1964P receive FDA 510(k) clearance?

ARTHREX CROSSPIN, MODEL AR-1964P received FDA 510(k) clearance on 2007-03-06, under 510(k) number K063719.

Who is the listed applicant for ARTHREX CROSSPIN, MODEL AR-1964P?

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 CROSSPIN, MODEL AR-1964P?

The FDA product code for ARTHREX CROSSPIN, MODEL AR-1964P is HTY.

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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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