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FDA 510(k)

Velora Acetabular System

K-Number: K252067 · 2025-12-05

Decision Date2025-12-05
Product CodeLPH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Velora Acetabular System is a medical device manufactured by Restor3D, Inc.. It received FDA 510(k) clearance on 2025-12-05 under approval number K252067. The device is classified under product code LPH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Velora Acetabular System?

Velora Acetabular System is a medical device that received FDA 510(k) clearance on 2025-12-05. It is manufactured by Restor3D, Inc.. The 510(k) number is K252067.

When was Velora Acetabular System approved by the FDA?

Velora Acetabular System received FDA 510(k) clearance on 2025-12-05, under approval number K252067.

What company makes Velora Acetabular System?

Velora Acetabular System is manufactured by Restor3D, Inc..

What is the FDA product code for Velora Acetabular System?

The FDA product code for Velora Acetabular System is LPH.

Related Clinical Trials

Other Devices by Restor3D, Inc.

Related Devices (Code: LPH)

Official Source

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