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FDA 510(k)

OSTEO TIBIA NAIL

K-Number: K922196 · 1992-07-23

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

Device Summary

OSTEO TIBIA NAIL 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 K922196. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OSTEO TIBIA NAIL?

OSTEO TIBIA NAIL 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 K922196.

When did OSTEO TIBIA NAIL receive FDA 510(k) clearance?

OSTEO TIBIA NAIL received FDA 510(k) clearance on 1992-07-23, under 510(k) number K922196.

Who is the listed applicant for OSTEO TIBIA NAIL?

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 TIBIA NAIL?

The FDA product code for OSTEO TIBIA NAIL is HSB.

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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 NAILK922193OSTEO KIRSCHNER WIREK920149OSTEO EX-FI-REK920037OSTEO COMPRESSION HIP SCREW

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Related Devices (Code: HSB)

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.

K261345Pediatric Nailing Platform FemurOrthoPediatrics Corp.K261481Pangea Femur Reconstruction SystemStryker GmbHK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.

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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