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FDA 510(k)

TRAUMA-FIX EXTERNAL FIXATOR

K-Number: K971272 · 1997-06-05

ApplicantTrend Medical, Inc.
Decision Date1997-06-05
Product CodeKTW
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

TRAUMA-FIX EXTERNAL FIXATOR is the device name listed in this FDA 510(k) record. The listed applicant is Trend Medical, Inc.. It received FDA 510(k) clearance on 1997-06-05 under 510(k) number K971272. The device is classified under product code KTW. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRAUMA-FIX EXTERNAL FIXATOR?

TRAUMA-FIX EXTERNAL FIXATOR is a medical device that received FDA 510(k) clearance on 1997-06-05. The listed applicant is Trend Medical, Inc.. The 510(k) number is K971272.

When did TRAUMA-FIX EXTERNAL FIXATOR receive FDA 510(k) clearance?

TRAUMA-FIX EXTERNAL FIXATOR received FDA 510(k) clearance on 1997-06-05, under 510(k) number K971272.

Who is the listed applicant for TRAUMA-FIX EXTERNAL FIXATOR?

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

What is the FDA product code for TRAUMA-FIX EXTERNAL FIXATOR?

The FDA product code for TRAUMA-FIX EXTERNAL FIXATOR is KTW.

Related Clinical Trials

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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Other records listing Trend 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.

K854754PATIENTMATE TMK853184PIGGYMATE I.V. TUBING LOCKK780861ELECTRONIC CLINICAL THERMOMETER

Related Devices (Code: KTW)

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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