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FDA 510(k)

ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMS

K-Number: K941364 · 1994-05-16

ApplicantAcufex Microsurgical, Inc.
Decision Date1994-05-16
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMS 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 1994-05-16 under 510(k) number K941364. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMS?

ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMS is a medical device that received FDA 510(k) clearance on 1994-05-16. The listed applicant is Acufex Microsurgical, Inc.. The 510(k) number is K941364.

When did ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMS receive FDA 510(k) clearance?

ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMS received FDA 510(k) clearance on 1994-05-16, under 510(k) number K941364.

Who is the listed applicant for ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMS?

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 T-FIX ROTATOR CUFF GUIDE SYSTEMS?

The FDA product code for ACUFEX T-FIX ROTATOR CUFF GUIDE SYSTEMS is HRX.

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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: HRX)

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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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