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FDA 510(k)

MINI-H-FIXATION

K-Number: K792561 · 1979-12-19

ApplicantGeny Medical, Inc.
Decision Date1979-12-19
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

MINI-H-FIXATION is the device name listed in this FDA 510(k) record. The listed applicant is Geny Medical, Inc.. It received FDA 510(k) clearance on 1979-12-19 under 510(k) number K792561. 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 MINI-H-FIXATION?

MINI-H-FIXATION is a medical device that received FDA 510(k) clearance on 1979-12-19. The listed applicant is Geny Medical, Inc.. The 510(k) number is K792561.

When did MINI-H-FIXATION receive FDA 510(k) clearance?

MINI-H-FIXATION received FDA 510(k) clearance on 1979-12-19, under 510(k) number K792561.

Who is the listed applicant for MINI-H-FIXATION?

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

What is the FDA product code for MINI-H-FIXATION?

The FDA product code for MINI-H-FIXATION is JEC.

Related Clinical Trials

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Other records listing Geny Medical, Inc. 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.

K001146GENYX FLEXIBLE INJECTION NEEEDLE

Related Devices (Code: JEC)

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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