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FDA 510(k)

Pro-X1™ Trochanteric Nailing System

K-Number: K221621 · 2023-03-06

ApplicantX-Bolt Orthopedics
Decision Date2023-03-06
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Pro-X1™ Trochanteric Nailing System is the device name listed in this FDA 510(k) record. The listed applicant is X-Bolt Orthopedics. It received FDA 510(k) clearance on 2023-03-06 under 510(k) number K221621. 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 Pro-X1™ Trochanteric Nailing System?

Pro-X1™ Trochanteric Nailing System is a medical device that received FDA 510(k) clearance on 2023-03-06. The listed applicant is X-Bolt Orthopedics. The 510(k) number is K221621.

When did Pro-X1™ Trochanteric Nailing System receive FDA 510(k) clearance?

Pro-X1™ Trochanteric Nailing System received FDA 510(k) clearance on 2023-03-06, under 510(k) number K221621.

Who is the listed applicant for Pro-X1™ Trochanteric Nailing System?

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

What is the FDA product code for Pro-X1™ Trochanteric Nailing System?

The FDA product code for Pro-X1™ Trochanteric Nailing 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

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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