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FDA 510(k)

REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX

K-Number: K091309 · 2009-11-05

ApplicantDgimed Ortho, Inc.
Decision Date2009-11-05
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX is the device name listed in this FDA 510(k) record. The listed applicant is Dgimed Ortho, Inc.. It received FDA 510(k) clearance on 2009-11-05 under 510(k) number K091309. 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 REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX?

REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX is a medical device that received FDA 510(k) clearance on 2009-11-05. The listed applicant is Dgimed Ortho, Inc.. The 510(k) number is K091309.

When did REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX receive FDA 510(k) clearance?

REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX received FDA 510(k) clearance on 2009-11-05, under 510(k) number K091309.

Who is the listed applicant for REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX?

The FDA 510(k) record lists Dgimed Ortho, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX?

The FDA product code for REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX is HSB.

Related Clinical Trials

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Other records listing Dgimed Ortho, Inc. 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.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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