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FDA 510(k)

Precice® Screws

K-Number: K193617 · 2020-05-08

ApplicantNuvasive Specialized Orthopedics, Inc.
Decision Date2020-05-08
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Precice® Screws is a medical device manufactured by Nuvasive Specialized Orthopedics, Inc.. It received FDA 510(k) clearance on 2020-05-08 under approval number K193617. 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® Screws?

Precice® Screws is a medical device that received FDA 510(k) clearance on 2020-05-08. It is manufactured by Nuvasive Specialized Orthopedics, Inc.. The 510(k) number is K193617.

When was Precice® Screws approved by the FDA?

Precice® Screws received FDA 510(k) clearance on 2020-05-08, under approval number K193617.

What company makes Precice® Screws?

Precice® Screws is manufactured by Nuvasive Specialized Orthopedics, Inc..

What is the FDA product code for Precice® Screws?

The FDA product code for Precice® Screws is HSB.

Other Devices by Nuvasive Specialized Orthopedics, Inc.

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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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