ACR Screw System
K-Number: K222245 · 2023-08-21
ApplicantBiomaterials Korea, Inc.
Decision Date2023-08-21
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
ACR Screw System is a medical device manufactured by Biomaterials Korea, Inc.. It received FDA 510(k) clearance on 2023-08-21 under approval number K222245. The device is classified under product code OAT. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the ACR Screw System?
ACR Screw System is a medical device that received FDA 510(k) clearance on 2023-08-21. It is manufactured by Biomaterials Korea, Inc.. The 510(k) number is K222245.
When was ACR Screw System approved by the FDA?
ACR Screw System received FDA 510(k) clearance on 2023-08-21, under approval number K222245.
What company makes ACR Screw System?
ACR Screw System is manufactured by Biomaterials Korea, Inc..
What is the FDA product code for ACR Screw System?
The FDA product code for ACR Screw System is OAT.
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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.