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FDA 510(k)

ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM

K-Number: K911398 · 1991-06-27

ApplicantHowmedica Corp.
Decision Date1991-06-27
Product CodeHWC
Advisory CommitteeOR
DecisionSubstantially Equivalent for Some Indications

Device Summary

ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1991-06-27 under 510(k) number K911398. 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 for Some Indications.

Frequently Asked Questions

What is the ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM?

ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM is a medical device that received FDA 510(k) clearance on 1991-06-27. The listed applicant is Howmedica Corp.. The 510(k) number is K911398.

When did ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM receive FDA 510(k) clearance?

ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM received FDA 510(k) clearance on 1991-06-27, under 510(k) number K911398.

Who is the listed applicant for ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM?

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

What is the FDA product code for ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM?

The FDA product code for ASNIS 2 SMALL DIAMETER CANNULATED SCREW SYSTEM is HWC. This falls under the Cardiovascular category.

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Other records listing Howmedica Corp. as applicant

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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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