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FDA 510(k)

Precice Ankle Salvage System

K-Number: K230765 · 2023-08-29

ApplicantNuvasive Specialized Orthopedics, Inc.
Decision Date2023-08-29
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Precice Ankle Salvage System is a medical device manufactured by Nuvasive Specialized Orthopedics, Inc.. It received FDA 510(k) clearance on 2023-08-29 under approval number K230765. 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 Precice Ankle Salvage System?

Precice Ankle Salvage System is a medical device that received FDA 510(k) clearance on 2023-08-29. It is manufactured by Nuvasive Specialized Orthopedics, Inc.. The 510(k) number is K230765.

When was Precice Ankle Salvage System approved by the FDA?

Precice Ankle Salvage System received FDA 510(k) clearance on 2023-08-29, under approval number K230765.

What company makes Precice Ankle Salvage System?

Precice Ankle Salvage System is manufactured by Nuvasive Specialized Orthopedics, Inc..

What is the FDA product code for Precice Ankle Salvage System?

The FDA product code for Precice Ankle Salvage System is 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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