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FDA 510(k)

ACUFEX CANNULATED BONE TUNNEL PLUGS

K-Number: K925437 · 1992-12-24

ApplicantCufex Microsurgical, Inc.
Decision Date1992-12-24
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ACUFEX CANNULATED BONE TUNNEL PLUGS is the device name listed in this FDA 510(k) record. The listed applicant is Cufex Microsurgical, Inc.. It received FDA 510(k) clearance on 1992-12-24 under 510(k) number K925437. 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 CANNULATED BONE TUNNEL PLUGS?

ACUFEX CANNULATED BONE TUNNEL PLUGS is a medical device that received FDA 510(k) clearance on 1992-12-24. The listed applicant is Cufex Microsurgical, Inc.. The 510(k) number is K925437.

When did ACUFEX CANNULATED BONE TUNNEL PLUGS receive FDA 510(k) clearance?

ACUFEX CANNULATED BONE TUNNEL PLUGS received FDA 510(k) clearance on 1992-12-24, under 510(k) number K925437.

Who is the listed applicant for ACUFEX CANNULATED BONE TUNNEL PLUGS?

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

What is the FDA product code for ACUFEX CANNULATED BONE TUNNEL PLUGS?

The FDA product code for ACUFEX CANNULATED BONE TUNNEL PLUGS is HRX.

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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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