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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 a medical device manufactured by Pacific Instruments. It received FDA 510(k) clearance on 2022-02-17 under approval 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. It is manufactured by Pacific Instruments. The 510(k) number is K213982.

When was Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires approved by the FDA?

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

What company makes Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires?

Pacific Instruments Orthopedic Fixation Pins and Wires / Kirschner / Guide Wires is manufactured by Pacific Instruments.

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 Clinical Trials

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Related PubMed Literature

PMID: 40528079 The Challenges in the Regulatory Approval of Additive-Manufactured Medical Devices: A Quantitative Survey. Therapeutic innovation & regulatory science (2025)

Related Devices (Code: HTY)

K161489Syntorr K-wire and Pin SystemSyntorr, Inc. K160264Additive Orthopaedics Hammertoe Correction SystemAdditive Orthopaedics, LLC K160194StarFuse Interphalangeal PinPhalanx Innovations K152662S-WireSpinal Resources, Inc. K153204In2Bones Kirschner wireIn2bones Sas K152627IFS Fixation Scaffold SystemMetric Medical Devices, Inc.

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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