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FDA 510(k)

K-WIRES AND STEINMANN PINS

K-Number: K941434 · 1994-10-03

ApplicantOmega Surgical Instruments, Inc.
Decision Date1994-10-03
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

K-WIRES AND STEINMANN PINS is the device name listed in this FDA 510(k) record. The listed applicant is Omega Surgical Instruments, Inc.. It received FDA 510(k) clearance on 1994-10-03 under 510(k) number K941434. 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-WIRES AND STEINMANN PINS?

K-WIRES AND STEINMANN PINS is a medical device that received FDA 510(k) clearance on 1994-10-03. The listed applicant is Omega Surgical Instruments, Inc.. The 510(k) number is K941434.

When did K-WIRES AND STEINMANN PINS receive FDA 510(k) clearance?

K-WIRES AND STEINMANN PINS received FDA 510(k) clearance on 1994-10-03, under 510(k) number K941434.

Who is the listed applicant for K-WIRES AND STEINMANN PINS?

The FDA 510(k) record lists Omega Surgical Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for K-WIRES AND STEINMANN PINS?

The FDA product code for K-WIRES AND STEINMANN PINS is HTY.

Related Clinical Trials

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Other records listing Omega Surgical Instruments, 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.

K933595BUR, SURGICAL, GENERAL & PLASTIC SURGERYK933298SAW BLADE

Related Devices (Code: HTY)

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

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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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