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FDA 510(k)

ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT

K-Number: K071456 · 2008-01-17

ApplicantArthrex, Inc.
Decision Date2008-01-17
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT is the device name listed in this FDA 510(k) record. The listed applicant is Arthrex, Inc.. It received FDA 510(k) clearance on 2008-01-17 under 510(k) number K071456. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT?

ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT is a medical device that received FDA 510(k) clearance on 2008-01-17. The listed applicant is Arthrex, Inc.. The 510(k) number is K071456.

When did ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT receive FDA 510(k) clearance?

ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT received FDA 510(k) clearance on 2008-01-17, under 510(k) number K071456.

Who is the listed applicant for ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT?

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 PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT?

The FDA product code for ARTHREX PROSTOP PLUS ARTHROEREISIS SUBTALAR IMPLANT is MAI.

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Related Devices (Code: MAI)

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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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