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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 a medical device manufactured by X-Bolt Orthopaedics. It received FDA 510(k) clearance on 2018-10-12 under approval 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. It is manufactured by X-Bolt Orthopaedics. The 510(k) number is K181640.

When was X-BOLT Hip Fracture Fixation System approved by the FDA?

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

What company makes X-BOLT Hip Fracture Fixation System?

X-BOLT Hip Fracture Fixation System is manufactured by X-Bolt Orthopaedics.

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 Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT07277946 AtraUmatic Laparoscopic HerNia Repair Clinical Investigation to Evaluate the Safety and Performance of The ECLIPSIUM System for Mesh Fixation IDE RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07574554 Fixation of Mandibular Angle Fracture Using 3D Titanium Miniplate Versus Standard Two Plate Fixation ACTIVE_NOT_RECRUITING NCT04389749 Continuous Passive Motion Following Fixation of Pelvic and Knee Fractures RECRUITING NCT06409559 Rim Plate to Buttress Plate for Posterior Wall Acetabular Fractures With and Without Inter-fragmentary Screws RECRUITING

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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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