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FDA 510(k)

HOFFMAN XPRESS LINE EXTENSION

K-Number: K092834 · 2009-10-08

ApplicantHowmedica Osteonics Corp.
Decision Date2009-10-08
Product CodeKTT
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HOFFMAN XPRESS LINE EXTENSION is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Osteonics Corp.. It received FDA 510(k) clearance on 2009-10-08 under 510(k) number K092834. The device is classified under product code KTT. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOFFMAN XPRESS LINE EXTENSION?

HOFFMAN XPRESS LINE EXTENSION is a medical device that received FDA 510(k) clearance on 2009-10-08. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K092834.

When did HOFFMAN XPRESS LINE EXTENSION receive FDA 510(k) clearance?

HOFFMAN XPRESS LINE EXTENSION received FDA 510(k) clearance on 2009-10-08, under 510(k) number K092834.

Who is the listed applicant for HOFFMAN XPRESS LINE EXTENSION?

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

What is the FDA product code for HOFFMAN XPRESS LINE EXTENSION?

The FDA product code for HOFFMAN XPRESS LINE EXTENSION is KTT.

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Related Devices (Code: KTT)

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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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