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FDA 510(k)

BONUTTI ANCHOR

K-Number: K934183 · 1996-04-03

ApplicantApogee Medical Products, Inc.
Decision Date1996-04-03
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

BONUTTI ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Apogee Medical Products, Inc.. It received FDA 510(k) clearance on 1996-04-03 under 510(k) number K934183. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent for Some Indications.

Frequently Asked Questions

What is the BONUTTI ANCHOR?

BONUTTI ANCHOR is a medical device that received FDA 510(k) clearance on 1996-04-03. The listed applicant is Apogee Medical Products, Inc.. The 510(k) number is K934183.

When did BONUTTI ANCHOR receive FDA 510(k) clearance?

BONUTTI ANCHOR received FDA 510(k) clearance on 1996-04-03, under 510(k) number K934183.

Who is the listed applicant for BONUTTI ANCHOR?

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

What is the FDA product code for BONUTTI ANCHOR?

The FDA product code for BONUTTI ANCHOR is MBI.

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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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