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FDA 510(k)

DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM

K-Number: K100312 · 2010-04-20

ApplicantDgimed Ortho, Inc.
Decision Date2010-04-20
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM 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 2010-04-20 under 510(k) number K100312. 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 DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM?

DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM is a medical device that received FDA 510(k) clearance on 2010-04-20. The listed applicant is Dgimed Ortho, Inc.. The 510(k) number is K100312.

When did DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM receive FDA 510(k) clearance?

DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM received FDA 510(k) clearance on 2010-04-20, under 510(k) number K100312.

Who is the listed applicant for DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM?

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 DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM?

The FDA product code for DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM 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.

K091309REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX

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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