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FDA 510(k)

PRECICE UNYTE CoCr System

K-Number: K162927 · 2017-04-06

ApplicantNuvasive Specialized Orthopedics, Inc.
Decision Date2017-04-06
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PRECICE UNYTE CoCr System is the device name listed in this FDA 510(k) record. The listed applicant is Nuvasive Specialized Orthopedics, Inc.. It received FDA 510(k) clearance on 2017-04-06 under 510(k) number K162927. 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 UNYTE CoCr System?

PRECICE UNYTE CoCr System is a medical device that received FDA 510(k) clearance on 2017-04-06. The listed applicant is Nuvasive Specialized Orthopedics, Inc.. The 510(k) number is K162927.

When did PRECICE UNYTE CoCr System receive FDA 510(k) clearance?

PRECICE UNYTE CoCr System received FDA 510(k) clearance on 2017-04-06, under 510(k) number K162927.

Who is the listed applicant for PRECICE UNYTE CoCr System?

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

What is the FDA product code for PRECICE UNYTE CoCr System?

The FDA product code for PRECICE UNYTE CoCr System is HSB.

Other records listing Nuvasive Specialized Orthopedics, Inc. as applicant

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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.

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

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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