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FDA 510(k)

X-BOLT Hip Fracture Fixation System

K-Number: K181640 · 2018-10-12

ApplicantX-Bolt Orthopaedics
Decision Date2018-10-12
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

X-BOLT Hip Fracture Fixation System is the device name listed in this FDA 510(k) record. The listed applicant is X-Bolt Orthopaedics. It received FDA 510(k) clearance on 2018-10-12 under 510(k) number K181640. 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 X-BOLT Hip Fracture Fixation System?

X-BOLT Hip Fracture Fixation System is a medical device that received FDA 510(k) clearance on 2018-10-12. The listed applicant is X-Bolt Orthopaedics. The 510(k) number is K181640.

When did X-BOLT Hip Fracture Fixation System receive FDA 510(k) clearance?

X-BOLT Hip Fracture Fixation System received FDA 510(k) clearance on 2018-10-12, under 510(k) number K181640.

Who is the listed applicant for X-BOLT Hip Fracture Fixation System?

The FDA 510(k) record lists X-Bolt Orthopaedics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for X-BOLT Hip Fracture Fixation System?

The FDA product code for X-BOLT Hip Fracture Fixation System is HSB.

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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