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FDA 510(k)

VERTAPLEX HV (SINGLE PACK AND DUAL PACK)

K-Number: K091606 · 2009-10-23

ApplicantStryker Corp.
Decision Date2009-10-23
Product CodeNDN
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VERTAPLEX HV (SINGLE PACK AND DUAL PACK) is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Corp.. It received FDA 510(k) clearance on 2009-10-23 under 510(k) number K091606. 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 VERTAPLEX HV (SINGLE PACK AND DUAL PACK)?

VERTAPLEX HV (SINGLE PACK AND DUAL PACK) is a medical device that received FDA 510(k) clearance on 2009-10-23. The listed applicant is Stryker Corp.. The 510(k) number is K091606.

When did VERTAPLEX HV (SINGLE PACK AND DUAL PACK) receive FDA 510(k) clearance?

VERTAPLEX HV (SINGLE PACK AND DUAL PACK) received FDA 510(k) clearance on 2009-10-23, under 510(k) number K091606.

Who is the listed applicant for VERTAPLEX HV (SINGLE PACK AND DUAL PACK)?

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

What is the FDA product code for VERTAPLEX HV (SINGLE PACK AND DUAL PACK)?

The FDA product code for VERTAPLEX HV (SINGLE PACK AND DUAL PACK) 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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