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FDA 510(k)

AGEE EXTERNAL FIXATOR

K-Number: K842493 · 1985-02-13

ApplicantThe Hand Biomechanics Research Laboratory
Decision Date1985-02-13
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

AGEE EXTERNAL FIXATOR is the device name listed in this FDA 510(k) record. The listed applicant is The Hand Biomechanics Research Laboratory. It received FDA 510(k) clearance on 1985-02-13 under 510(k) number K842493. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AGEE EXTERNAL FIXATOR?

AGEE EXTERNAL FIXATOR is a medical device that received FDA 510(k) clearance on 1985-02-13. The listed applicant is The Hand Biomechanics Research Laboratory. The 510(k) number is K842493.

When did AGEE EXTERNAL FIXATOR receive FDA 510(k) clearance?

AGEE EXTERNAL FIXATOR received FDA 510(k) clearance on 1985-02-13, under 510(k) number K842493.

Who is the listed applicant for AGEE EXTERNAL FIXATOR?

The FDA 510(k) record lists The Hand Biomechanics Research Laboratory as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AGEE EXTERNAL FIXATOR?

The FDA product code for AGEE EXTERNAL FIXATOR is JEC.

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Related Devices (Code: JEC)

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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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