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FDA 510(k)

ASNIS GUIDED SCREW SYSTEMS

K-Number: K801969 · 1980-08-27

ApplicantHowmedica Corp.
Decision Date1980-08-27
Product CodeHNC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

ASNIS GUIDED SCREW SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Howmedica Corp.. It received FDA 510(k) clearance on 1980-08-27 under 510(k) number K801969. The device is classified under product code HNC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASNIS GUIDED SCREW SYSTEMS?

ASNIS GUIDED SCREW SYSTEMS is a medical device that received FDA 510(k) clearance on 1980-08-27. The listed applicant is Howmedica Corp.. The 510(k) number is K801969.

When did ASNIS GUIDED SCREW SYSTEMS receive FDA 510(k) clearance?

ASNIS GUIDED SCREW SYSTEMS received FDA 510(k) clearance on 1980-08-27, under 510(k) number K801969.

Who is the listed applicant for ASNIS GUIDED SCREW SYSTEMS?

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 GUIDED SCREW SYSTEMS?

The FDA product code for ASNIS GUIDED SCREW SYSTEMS is HNC.

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Other records listing Howmedica Corp. as applicant

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Related Devices (Code: HNC)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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