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FDA 510(k)

OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM

K-Number: K090091 · 2009-02-01

ApplicantMylad Orthopedic Solutions, LLC
Decision Date2009-02-01
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Mylad Orthopedic Solutions, LLC. It received FDA 510(k) clearance on 2009-02-01 under 510(k) number K090091. 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 OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM?

OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2009-02-01. The listed applicant is Mylad Orthopedic Solutions, LLC. The 510(k) number is K090091.

When did OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM receive FDA 510(k) clearance?

OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM received FDA 510(k) clearance on 2009-02-01, under 510(k) number K090091.

Who is the listed applicant for OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM?

The FDA 510(k) record lists Mylad Orthopedic Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM?

The FDA product code for OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM is HSB.

Related Clinical Trials

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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Other records listing Mylad Orthopedic Solutions, LLC 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.

K081356OLECRANAIL INTRAMEDULLARY FIXATION SYSTEM

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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