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FDA 510(k)

FIXATION PINS/WIRES

K-Number: K943856 · 1995-07-06

ApplicantAcu Med, Inc.
Decision Date1995-07-06
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FIXATION PINS/WIRES 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 1995-07-06 under 510(k) number K943856. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIXATION PINS/WIRES?

FIXATION PINS/WIRES is a medical device that received FDA 510(k) clearance on 1995-07-06. The listed applicant is Acu Med, Inc.. The 510(k) number is K943856.

When did FIXATION PINS/WIRES receive FDA 510(k) clearance?

FIXATION PINS/WIRES received FDA 510(k) clearance on 1995-07-06, under 510(k) number K943856.

Who is the listed applicant for FIXATION PINS/WIRES?

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 FIXATION PINS/WIRES?

The FDA product code for FIXATION PINS/WIRES is HTY.

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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.

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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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