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FDA 510(k)

CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM

K-Number: K113762 · 2012-02-06

ApplicantArthrosurface, Inc.
Decision Date2012-02-06
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Arthrosurface, Inc.. It received FDA 510(k) clearance on 2012-02-06 under 510(k) number K113762. 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 CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM?

CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM is a medical device that received FDA 510(k) clearance on 2012-02-06. The listed applicant is Arthrosurface, Inc.. The 510(k) number is K113762.

When did CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM receive FDA 510(k) clearance?

CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM received FDA 510(k) clearance on 2012-02-06, under 510(k) number K113762.

Who is the listed applicant for CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM?

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

What is the FDA product code for CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM?

The FDA product code for CHECKMATE METATARSO-PHALANGEAL (MTP) ARTHRODESIS SYSTEM is HRS.

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Other records listing Arthrosurface, Inc. as applicant

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Related Devices (Code: HRS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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