PRECICE UNYTE CoCr System
K-Number: K162927 · 2017-04-06
Decision Date2017-04-06
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
PRECICE UNYTE CoCr System is a medical device manufactured by Nuvasive Specialized Orthopedics, Inc.. It received FDA 510(k) clearance on 2017-04-06 under approval number K162927. 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 UNYTE CoCr System?
PRECICE UNYTE CoCr System is a medical device that received FDA 510(k) clearance on 2017-04-06. It is manufactured by Nuvasive Specialized Orthopedics, Inc.. The 510(k) number is K162927.
When was PRECICE UNYTE CoCr System approved by the FDA?
PRECICE UNYTE CoCr System received FDA 510(k) clearance on 2017-04-06, under approval number K162927.
What company makes PRECICE UNYTE CoCr System?
PRECICE UNYTE CoCr System is manufactured by Nuvasive Specialized Orthopedics, Inc..
What is the FDA product code for PRECICE UNYTE CoCr System?
The FDA product code for PRECICE UNYTE CoCr System 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.