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FDA 510(k)

Precice Intramedullary Limb Lengthening System

K-Number: K220234 · 2023-03-15

ApplicantNuvasive Specialized Orthopedics, Inc.
Decision Date2023-03-15
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Precice Intramedullary Limb Lengthening 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 2023-03-15 under 510(k) number K220234. 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 Intramedullary Limb Lengthening System?

Precice Intramedullary Limb Lengthening System is a medical device that received FDA 510(k) clearance on 2023-03-15. The listed applicant is Nuvasive Specialized Orthopedics, Inc.. The 510(k) number is K220234.

When did Precice Intramedullary Limb Lengthening System receive FDA 510(k) clearance?

Precice Intramedullary Limb Lengthening System received FDA 510(k) clearance on 2023-03-15, under 510(k) number K220234.

Who is the listed applicant for Precice Intramedullary Limb Lengthening 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 Intramedullary Limb Lengthening System?

The FDA product code for Precice Intramedullary Limb Lengthening 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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