USTAR II System
K-Number: K190100 · 2019-09-23
ApplicantUnited Orthopedic Corporation
Decision Date2019-09-23
Product CodeKRO
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
USTAR II System is a medical device manufactured by United Orthopedic Corporation. It received FDA 510(k) clearance on 2019-09-23 under approval number K190100. The device is classified under product code KRO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the USTAR II System?
USTAR II System is a medical device that received FDA 510(k) clearance on 2019-09-23. It is manufactured by United Orthopedic Corporation. The 510(k) number is K190100.
When was USTAR II System approved by the FDA?
USTAR II System received FDA 510(k) clearance on 2019-09-23, under approval number K190100.
What company makes USTAR II System?
USTAR II System is manufactured by United Orthopedic Corporation.
What is the FDA product code for USTAR II System?
The FDA product code for USTAR II System is KRO.
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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.