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FDA 510(k)

EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM

K-Number: K093978 · 2010-05-11

ApplicantExactech, Inc.
Decision Date2010-05-11
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2010-05-11 under 510(k) number K093978. 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 EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM?

EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM is a medical device that received FDA 510(k) clearance on 2010-05-11. The listed applicant is Exactech, Inc.. The 510(k) number is K093978.

When did EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM receive FDA 510(k) clearance?

EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM received FDA 510(k) clearance on 2010-05-11, under 510(k) number K093978.

Who is the listed applicant for EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM?

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

What is the FDA product code for EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEM?

The FDA product code for EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE 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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