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FDA 510(k)

EXTERNAL FIXATOR

K-Number: K943857 · 1995-01-27

ApplicantAcu Med, Inc.
Decision Date1995-01-27
Product CodeJEC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

EXTERNAL FIXATOR is the device name listed in this FDA 510(k) record. The listed applicant is Acu Med, Inc.. It received FDA 510(k) clearance on 1995-01-27 under 510(k) number K943857. The device is classified under product code JEC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the EXTERNAL FIXATOR?

EXTERNAL FIXATOR is a medical device that received FDA 510(k) clearance on 1995-01-27. The listed applicant is Acu Med, Inc.. The 510(k) number is K943857.

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

EXTERNAL FIXATOR received FDA 510(k) clearance on 1995-01-27, under 510(k) number K943857.

Who is the listed applicant for EXTERNAL FIXATOR?

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

What is the FDA product code for EXTERNAL FIXATOR?

The FDA product code for EXTERNAL FIXATOR is JEC.

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Other records listing Acu Med, 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.

K021321WRIST FUSION PLATEK013616POLARUS CAP SCREWK012655CONGRUENT BONE PLATE SYSTEMK992525ACUMED MODULAR SHOULDER SYSTEMK993657ACUMED SUTURE ANCHORK980103ACUMED SUTURE ANCHOR

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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

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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