FDA 510(k)

FRAMELOCK; FRAMELOCK ACCESSORIES

K-Number: K022370 · 2002-10-18

Decision Date2002-10-18

Product CodeHBG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

FRAMELOCK; FRAMELOCK ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Xomed, Inc.. It received FDA 510(k) clearance on 2002-10-18 under 510(k) number K022370. The device is classified under product code HBG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FRAMELOCK; FRAMELOCK ACCESSORIES?

FRAMELOCK; FRAMELOCK ACCESSORIES is a medical device that received FDA 510(k) clearance on 2002-10-18. The listed applicant is Medtronic Xomed, Inc.. The 510(k) number is K022370.

When did FRAMELOCK; FRAMELOCK ACCESSORIES receive FDA 510(k) clearance?

FRAMELOCK; FRAMELOCK ACCESSORIES received FDA 510(k) clearance on 2002-10-18, under 510(k) number K022370.

Who is the listed applicant for FRAMELOCK; FRAMELOCK ACCESSORIES?

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

What is the FDA product code for FRAMELOCK; FRAMELOCK ACCESSORIES?

The FDA product code for FRAMELOCK; FRAMELOCK ACCESSORIES is HBG.

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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.