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FDA 510(k)

ASNIS MICRO CANNULATED SCREW

K-Number: K071092 · 2007-05-11

ApplicantHowmedica Osteonics Corp.
Decision Date2007-05-11
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ASNIS MICRO CANNULATED SCREW 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 2007-05-11 under 510(k) number K071092. The device is classified under product code HWC. It was reviewed by the OR advisory panel. Product code HWC falls under the category of Cardiovascular, which includes vascular grafts and cardiovascular implants. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASNIS MICRO CANNULATED SCREW?

ASNIS MICRO CANNULATED SCREW is a medical device that received FDA 510(k) clearance on 2007-05-11. The listed applicant is Howmedica Osteonics Corp.. The 510(k) number is K071092.

When did ASNIS MICRO CANNULATED SCREW receive FDA 510(k) clearance?

ASNIS MICRO CANNULATED SCREW received FDA 510(k) clearance on 2007-05-11, under 510(k) number K071092.

Who is the listed applicant for ASNIS MICRO CANNULATED SCREW?

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 ASNIS MICRO CANNULATED SCREW?

The FDA product code for ASNIS MICRO CANNULATED SCREW is HWC. This falls under the Cardiovascular category.

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Related Devices (Code: HWC)

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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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