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FDA 510(k)

Vertex Hip Fracture Nailing System

K-Number: K233910 · 2024-04-04

ApplicantOrthoxel Dac
Decision Date2024-04-04
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Vertex Hip Fracture Nailing System is a medical device manufactured by Orthoxel Dac. It received FDA 510(k) clearance on 2024-04-04 under approval number K233910. 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 Vertex Hip Fracture Nailing System?

Vertex Hip Fracture Nailing System is a medical device that received FDA 510(k) clearance on 2024-04-04. It is manufactured by Orthoxel Dac. The 510(k) number is K233910.

When was Vertex Hip Fracture Nailing System approved by the FDA?

Vertex Hip Fracture Nailing System received FDA 510(k) clearance on 2024-04-04, under approval number K233910.

What company makes Vertex Hip Fracture Nailing System?

Vertex Hip Fracture Nailing System is manufactured by Orthoxel Dac.

What is the FDA product code for Vertex Hip Fracture Nailing System?

The FDA product code for Vertex Hip Fracture Nailing System is HSB.

Related Clinical Trials

NCT06571760 Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-I COMPLETED NCT07520851 Efficacy of the Buzzy System on Pain and Fear Reduction in Elbow Fracture Pin Removal RECRUITING NCT04015128 A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail GT ACTIVE_NOT_RECRUITING NCT04015154 A Post-Market Clinical Evaluation of the Treatment of Femur Fractures With the Femoral Nail PF COMPLETED NCT05773352 Perform® Humeral System - Fracture Study (PFX) ACTIVE_NOT_RECRUITING NCT06576427 Selective Pulmonary-artery Intervention to Reduce Acute Right-heart tEnsion-II COMPLETED

Related Devices (Code: HSB)

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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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