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FDA 510(k)

Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires

K-Number: K213982 · 2022-02-17

ApplicantPacific Instruments
Decision Date2022-02-17
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires is the device name listed in this FDA 510(k) record. The listed applicant is Pacific Instruments. It received FDA 510(k) clearance on 2022-02-17 under 510(k) number K213982. 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 Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires?

Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires is a medical device that received FDA 510(k) clearance on 2022-02-17. The listed applicant is Pacific Instruments. The 510(k) number is K213982.

When did Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires receive FDA 510(k) clearance?

Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires received FDA 510(k) clearance on 2022-02-17, under 510(k) number K213982.

Who is the listed applicant for Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires?

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

What is the FDA product code for Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires?

The FDA product code for Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires is HTY.

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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