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FDA 510(k)

EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER

K-Number: K071738 · 2007-08-15

ApplicantExactech, Inc.
Decision Date2007-08-15
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER is the device name listed in this FDA 510(k) record. The listed applicant is Exactech, Inc.. It received FDA 510(k) clearance on 2007-08-15 under 510(k) number K071738. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER?

EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER is a medical device that received FDA 510(k) clearance on 2007-08-15. The listed applicant is Exactech, Inc.. The 510(k) number is K071738.

When did EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER receive FDA 510(k) clearance?

EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER received FDA 510(k) clearance on 2007-08-15, under 510(k) number K071738.

Who is the listed applicant for EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER?

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 OPTETRAK PROXIMAL TIBIAL SPACER?

The FDA product code for EXACTECH OPTETRAK PROXIMAL TIBIAL SPACER is JWH.

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Related Devices (Code: JWH)

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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