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FDA 510(k)

HUENE FIXATION SCREW

K-Number: K910193 · 1991-08-23

ApplicantAcu-Med, Inc.
Decision Date1991-08-23
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

HUENE FIXATION SCREW 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 1991-08-23 under 510(k) number K910193. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the HUENE FIXATION SCREW?

HUENE FIXATION SCREW is a medical device that received FDA 510(k) clearance on 1991-08-23. The listed applicant is Acu-Med, Inc.. The 510(k) number is K910193.

When did HUENE FIXATION SCREW receive FDA 510(k) clearance?

HUENE FIXATION SCREW received FDA 510(k) clearance on 1991-08-23, under 510(k) number K910193.

Who is the listed applicant for HUENE FIXATION SCREW?

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 HUENE FIXATION SCREW?

The FDA product code for HUENE FIXATION SCREW is HWC. This falls under the Cardiovascular category.

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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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