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FDA 510(k)

TRIMED X-FIX

K-Number: K101375 · 2010-09-15

ApplicantTriMed, Inc.
Decision Date2010-09-15
Product CodeNDK
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRIMED X-FIX is the device name listed in this FDA 510(k) record. The listed applicant is TriMed, Inc.. It received FDA 510(k) clearance on 2010-09-15 under 510(k) number K101375. 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 TRIMED X-FIX?

TRIMED X-FIX is a medical device that received FDA 510(k) clearance on 2010-09-15. The listed applicant is TriMed, Inc.. The 510(k) number is K101375.

When did TRIMED X-FIX receive FDA 510(k) clearance?

TRIMED X-FIX received FDA 510(k) clearance on 2010-09-15, under 510(k) number K101375.

Who is the listed applicant for TRIMED X-FIX?

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

What is the FDA product code for TRIMED X-FIX?

The FDA product code for TRIMED X-FIX is NDK.

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Related Devices (Code: NDK)

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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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