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FDA 510(k)

Precice® Ankle Salvage System

K-Number: K200430 · 2020-09-16

ApplicantNuvasive Specialized Orthopedics, Inc.
Decision Date2020-09-16
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 2020-09-16 under approval number K200430. 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 2020-09-16. It is manufactured by Nuvasive Specialized Orthopedics, Inc.. The 510(k) number is K200430.

When was Precice® Ankle Salvage System approved by the FDA?

Precice® Ankle Salvage System received FDA 510(k) clearance on 2020-09-16, under approval number K200430.

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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