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FDA 510(k)

VerteLoc Spinal System

K-Number: K231134 · 2024-02-13

ApplicantSignature Orthopaedics Pty, Ltd.
Decision Date2024-02-13
Product CodeMQP
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

VerteLoc Spinal System is a medical device manufactured by Signature Orthopaedics Pty, Ltd.. It received FDA 510(k) clearance on 2024-02-13 under approval number K231134. The device is classified under product code MQP. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VerteLoc Spinal System?

VerteLoc Spinal System is a medical device that received FDA 510(k) clearance on 2024-02-13. It is manufactured by Signature Orthopaedics Pty, Ltd.. The 510(k) number is K231134.

When was VerteLoc Spinal System approved by the FDA?

VerteLoc Spinal System received FDA 510(k) clearance on 2024-02-13, under approval number K231134.

What company makes VerteLoc Spinal System?

VerteLoc Spinal System is manufactured by Signature Orthopaedics Pty, Ltd..

What is the FDA product code for VerteLoc Spinal System?

The FDA product code for VerteLoc Spinal System is MQP.

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Related PubMed Literature

PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022)

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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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