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FDA 510(k)

VERTEFIX VERTEBROPLASTY PROCEDURE SET

K-Number: K042691 · 2005-11-08

ApplicantCook, Inc.
Decision Date2005-11-08
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VERTEFIX VERTEBROPLASTY PROCEDURE SET is the device name listed in this FDA 510(k) record. The listed applicant is Cook, Inc.. It received FDA 510(k) clearance on 2005-11-08 under 510(k) number K042691. The device is classified under product code NDN. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VERTEFIX VERTEBROPLASTY PROCEDURE SET?

VERTEFIX VERTEBROPLASTY PROCEDURE SET is a medical device that received FDA 510(k) clearance on 2005-11-08. The listed applicant is Cook, Inc.. The 510(k) number is K042691.

When did VERTEFIX VERTEBROPLASTY PROCEDURE SET receive FDA 510(k) clearance?

VERTEFIX VERTEBROPLASTY PROCEDURE SET received FDA 510(k) clearance on 2005-11-08, under 510(k) number K042691.

Who is the listed applicant for VERTEFIX VERTEBROPLASTY PROCEDURE SET?

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

What is the FDA product code for VERTEFIX VERTEBROPLASTY PROCEDURE SET?

The FDA product code for VERTEFIX VERTEBROPLASTY PROCEDURE SET is NDN.

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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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