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FDA 510(k)

OSTEO KIRSCHNER WIRE

K-Number: K922193 · 1992-07-23

ApplicantOsteo AG
Decision Date1992-07-23
Product CodeHTY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEO KIRSCHNER WIRE is the device name listed in this FDA 510(k) record. The listed applicant is Osteo AG. It received FDA 510(k) clearance on 1992-07-23 under 510(k) number K922193. 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 OSTEO KIRSCHNER WIRE?

OSTEO KIRSCHNER WIRE is a medical device that received FDA 510(k) clearance on 1992-07-23. The listed applicant is Osteo AG. The 510(k) number is K922193.

When did OSTEO KIRSCHNER WIRE receive FDA 510(k) clearance?

OSTEO KIRSCHNER WIRE received FDA 510(k) clearance on 1992-07-23, under 510(k) number K922193.

Who is the listed applicant for OSTEO KIRSCHNER WIRE?

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

What is the FDA product code for OSTEO KIRSCHNER WIRE?

The FDA product code for OSTEO KIRSCHNER WIRE is HTY.

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Other records listing Osteo AG 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.

K933340OSTEO INTERLOCKING-COMPRESSION NAILK922194OSTEO STEINMANN PINK922195OSTEO FEMORAL NAILK922196OSTEO TIBIA NAILK920149OSTEO EX-FI-REK920037OSTEO COMPRESSION HIP SCREW

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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.

K262722Primal K-Wire (P99-193-1410)Paragon 28, Inc.K253325ZipToe™ Hammertoe Fusion SystemToetal SolutionsK252657Impact PEEK Union Nail SystemNvision Biomedical Technologies, Inc.K250315RONAVIS – FX (FX-001)AIRS, Inc.K251362PediFlex™ Flexible Nail SystemOrthoPediatrics Corp.K250646Impact PEEK Union Nail SystemNvision Biomedical Technologies

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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