PRECICE System
K-Number: K191336 · 2019-09-26
Decision Date2019-09-26
Product CodeHSB
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
PRECICE System is a medical device manufactured by Nuvasive Specialized Orthopedics, Inc.. It received FDA 510(k) clearance on 2019-09-26 under approval number K191336. 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 System?
PRECICE System is a medical device that received FDA 510(k) clearance on 2019-09-26. It is manufactured by Nuvasive Specialized Orthopedics, Inc.. The 510(k) number is K191336.
When was PRECICE System approved by the FDA?
PRECICE System received FDA 510(k) clearance on 2019-09-26, under approval number K191336.
What company makes PRECICE System?
PRECICE System is manufactured by Nuvasive Specialized Orthopedics, Inc..
What is the FDA product code for PRECICE System?
The FDA product code for PRECICE 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.