NewPrim System
K-Number: K191966 · 2020-02-13
ApplicantBrm Extremities
Decision Date2020-02-13
Product CodeKWH
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
NewPrim System is a medical device manufactured by Brm Extremities. It received FDA 510(k) clearance on 2020-02-13 under approval number K191966. The device is classified under product code KWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NewPrim System?
NewPrim System is a medical device that received FDA 510(k) clearance on 2020-02-13. It is manufactured by Brm Extremities. The 510(k) number is K191966.
When was NewPrim System approved by the FDA?
NewPrim System received FDA 510(k) clearance on 2020-02-13, under approval number K191966.
What company makes NewPrim System?
NewPrim System is manufactured by Brm Extremities.
What is the FDA product code for NewPrim System?
The FDA product code for NewPrim System is KWH.
Other Devices by Brm Extremities
Related Devices (Code: KWH)
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.