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FDA 510(k)

OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL

K-Number: K982601 · 1998-09-14

ApplicantOsteonics Corp.
Decision Date1998-09-14
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL is the device name listed in this FDA 510(k) record. The listed applicant is Osteonics Corp.. It received FDA 510(k) clearance on 1998-09-14 under 510(k) number K982601. 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 IC RETROGRADE/ANTEGRADE FEMORAL NAIL?

OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL is a medical device that received FDA 510(k) clearance on 1998-09-14. The listed applicant is Osteonics Corp.. The 510(k) number is K982601.

When did OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL receive FDA 510(k) clearance?

OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL received FDA 510(k) clearance on 1998-09-14, under 510(k) number K982601.

Who is the listed applicant for OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL?

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

What is the FDA product code for OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL?

The FDA product code for OSTEO IC RETROGRADE/ANTEGRADE FEMORAL NAIL is HSB.

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Other records listing Osteonics Corp. 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.

K983657OSTEONICS SERIES 7000 AD TIBIAL TRAYK980070OSTEONICS HA-COATED DEVICESK984375OSTEONICS SPINAL SYSTEM - SACRAL OFFSET CONNECTOR ASSEMBLYK982798OSTEONICS ANTERIOR CERVICAL COMPRESSION PLATING SYSTEMK984585OSTEONICS +10 UNIPOLAR ADAPTOR SLEEVEK990203OSTEONICS PRIMARY SECUR-FIT PLUS HIP STEMS

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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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