FDA 510(k)

PRECICE® BONE TRANSPORT System

K-Number: K182170 · 2019-02-05

ApplicantNuvasive Specialized Orthopedics, Inc.

Decision Date2019-02-05

Product CodeHSB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

PRECICE® BONE TRANSPORT System is a medical device manufactured by Nuvasive Specialized Orthopedics, Inc.. It received FDA 510(k) clearance on 2019-02-05 under approval number K182170. 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® BONE TRANSPORT System?

PRECICE® BONE TRANSPORT System is a medical device that received FDA 510(k) clearance on 2019-02-05. It is manufactured by Nuvasive Specialized Orthopedics, Inc.. The 510(k) number is K182170.

When was PRECICE® BONE TRANSPORT System approved by the FDA?

PRECICE® BONE TRANSPORT System received FDA 510(k) clearance on 2019-02-05, under approval number K182170.

What company makes PRECICE® BONE TRANSPORT System?

PRECICE® BONE TRANSPORT System is manufactured by Nuvasive Specialized Orthopedics, Inc..

What is the FDA product code for PRECICE® BONE TRANSPORT System?

The FDA product code for PRECICE® BONE TRANSPORT System is HSB.

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Related Devices (Code: 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.