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FDA 510(k)

EXTERNAL FIXATOR SYSTEM

K-Number: K122208 · 2012-12-20

ApplicantChristopher D. Endara
Decision Date2012-12-20
Product CodeNDK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXTERNAL FIXATOR SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Christopher D. Endara. It received FDA 510(k) clearance on 2012-12-20 under 510(k) number K122208. The device is classified under product code NDK. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTERNAL FIXATOR SYSTEM?

EXTERNAL FIXATOR SYSTEM is a medical device that received FDA 510(k) clearance on 2012-12-20. The listed applicant is Christopher D. Endara. The 510(k) number is K122208.

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

EXTERNAL FIXATOR SYSTEM received FDA 510(k) clearance on 2012-12-20, under 510(k) number K122208.

Who is the listed applicant for EXTERNAL FIXATOR SYSTEM?

The FDA 510(k) record lists Christopher D. Endara as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXTERNAL FIXATOR SYSTEM?

The FDA product code for EXTERNAL FIXATOR SYSTEM is NDK.

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Related Devices (Code: NDK)

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.

K101375TRIMED X-FIXTriMed, Inc.

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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