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FDA 510(k)

CENTRAFIX EXTERNAL FIXATOR

K-Number: K991732 · 1999-05-21

ApplicantOwandar Medical, Ltd.
Decision Date1999-05-21
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CENTRAFIX EXTERNAL FIXATOR is the device name listed in this FDA 510(k) record. The listed applicant is Owandar Medical, Ltd.. It received FDA 510(k) clearance on 1999-05-21 under 510(k) number K991732. 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 CENTRAFIX EXTERNAL FIXATOR?

CENTRAFIX EXTERNAL FIXATOR is a medical device that received FDA 510(k) clearance on 1999-05-21. The listed applicant is Owandar Medical, Ltd.. The 510(k) number is K991732.

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

CENTRAFIX EXTERNAL FIXATOR received FDA 510(k) clearance on 1999-05-21, under 510(k) number K991732.

Who is the listed applicant for CENTRAFIX EXTERNAL FIXATOR?

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

What is the FDA product code for CENTRAFIX EXTERNAL FIXATOR?

The FDA product code for CENTRAFIX 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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