FDA 510(k)

K-WIRE

K-Number: K960482 · 1996-04-09

ApplicantAmerican Medical Specialties, Inc.

Decision Date1996-04-09

Product CodeHTY

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

K-WIRE is the device name listed in this FDA 510(k) record. The listed applicant is American Medical Specialties, Inc.. It received FDA 510(k) clearance on 1996-04-09 under 510(k) number K960482. The device is classified under product code HTY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the K-WIRE?

K-WIRE is a medical device that received FDA 510(k) clearance on 1996-04-09. The listed applicant is American Medical Specialties, Inc.. The 510(k) number is K960482.

When did K-WIRE receive FDA 510(k) clearance?

K-WIRE received FDA 510(k) clearance on 1996-04-09, under 510(k) number K960482.

Who is the listed applicant for K-WIRE?

The FDA 510(k) record lists American Medical Specialties, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K-WIRE?

The FDA product code for K-WIRE is HTY.

Other records listing American Medical Specialties, Inc. as applicant

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.

K960483STEINMAN PIN K934603SURGICAL SAW BLADES K934583BURRS

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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.