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FDA 510(k)

ORTHOFIX FEMORAL NAILING SYTEM

K-Number: K973944 · 1997-12-19

ApplicantOrthofix Srl
Decision Date1997-12-19
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ORTHOFIX FEMORAL NAILING SYTEM is the device name listed in this FDA 510(k) record. The listed applicant is Orthofix Srl. It received FDA 510(k) clearance on 1997-12-19 under 510(k) number K973944. 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 ORTHOFIX FEMORAL NAILING SYTEM?

ORTHOFIX FEMORAL NAILING SYTEM is a medical device that received FDA 510(k) clearance on 1997-12-19. The listed applicant is Orthofix Srl. The 510(k) number is K973944.

When did ORTHOFIX FEMORAL NAILING SYTEM receive FDA 510(k) clearance?

ORTHOFIX FEMORAL NAILING SYTEM received FDA 510(k) clearance on 1997-12-19, under 510(k) number K973944.

Who is the listed applicant for ORTHOFIX FEMORAL NAILING SYTEM?

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

What is the FDA product code for ORTHOFIX FEMORAL NAILING SYTEM?

The FDA product code for ORTHOFIX FEMORAL NAILING SYTEM is HSB.

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Other records listing Orthofix Srl as applicant

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Related Devices (Code: HSB)

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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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