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FDA 510(k)

EXACTECH(TM)

K-Number: K863468 · 1986-12-08

ApplicantTravenol Laboratories, S.A.
Decision Date1986-12-08
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

EXACTECH(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Travenol Laboratories, S.A.. It received FDA 510(k) clearance on 1986-12-08 under 510(k) number K863468. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXACTECH(TM)?

EXACTECH(TM) is a medical device that received FDA 510(k) clearance on 1986-12-08. The listed applicant is Travenol Laboratories, S.A.. The 510(k) number is K863468.

When did EXACTECH(TM) receive FDA 510(k) clearance?

EXACTECH(TM) received FDA 510(k) clearance on 1986-12-08, under 510(k) number K863468.

Who is the listed applicant for EXACTECH(TM)?

The FDA 510(k) record lists Travenol Laboratories, S.A. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXACTECH(TM)?

The FDA product code for EXACTECH(TM) is CGA.

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Other records listing Travenol Laboratories, S.A. as applicant

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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Related Devices (Code: CGA)

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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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