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FDA 510(k)

PRECICE Trauma Nail System

K-Number: K160267 · 2016-03-31

ApplicantEllipse Technologies, Incorporated
Decision Date2016-03-31
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PRECICE Trauma Nail System is the device name listed in this FDA 510(k) record. The listed applicant is Ellipse Technologies, Incorporated. It received FDA 510(k) clearance on 2016-03-31 under 510(k) number K160267. 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 PRECICE Trauma Nail System?

PRECICE Trauma Nail System is a medical device that received FDA 510(k) clearance on 2016-03-31. The listed applicant is Ellipse Technologies, Incorporated. The 510(k) number is K160267.

When did PRECICE Trauma Nail System receive FDA 510(k) clearance?

PRECICE Trauma Nail System received FDA 510(k) clearance on 2016-03-31, under 510(k) number K160267.

Who is the listed applicant for PRECICE Trauma Nail System?

The FDA 510(k) record lists Ellipse Technologies, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRECICE Trauma Nail System?

The FDA product code for PRECICE Trauma Nail System is HSB.

Other records listing Ellipse Technologies, Incorporated 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.

K160325PRECICE Intramedullary Limb Lengthening SystemK151594Ellipse Supplemental Instrument Trays

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.

K261481Pangea Femur Reconstruction SystemStryker GmbHK261651Precice™ Max System and Precice™ Ankle Salvage SystemNuVasive Specialized OrthopedicsK253080AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)Suzhou and Science & Technology Development Corp.K253155Fule Metallic Lockable Intramedullary Nail SystemsBeijing Fule Science & Technology Development Co., Ltd.K253046HERA Interlocking Intramedullary Nailing SystemZheJiang Decans Medical Devices Co., Ltd.K260146FITBONE® TRANSPORT AND LENGTHENING SYSTEMOrthofix Srl

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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