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FDA 510(k)

ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW

K-Number: K954246 · 1996-02-15

ApplicantAcufex Microsurgical, Inc.
Decision Date1996-02-15
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW is the device name listed in this FDA 510(k) record. The listed applicant is Acufex Microsurgical, Inc.. It received FDA 510(k) clearance on 1996-02-15 under 510(k) number K954246. 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 ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW?

ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW is a medical device that received FDA 510(k) clearance on 1996-02-15. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K954246.

When did ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW receive FDA 510(k) clearance?

ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW received FDA 510(k) clearance on 1996-02-15, under 510(k) number K954246.

Who is the listed applicant for ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW?

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

What is the FDA product code for ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW?

The FDA product code for ACUFEX ENDOFIX ABSORBABLE INTERFERENCE SCREW is HWC. This falls under the Cardiovascular category.

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Other records listing Acufex Microsurgical, 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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Related Devices (Code: HWC)

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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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