OBS Anchorage Screw, Biokey Anchorage Screw
K-Number: K202278 · 2021-01-08
ApplicantBomei Co, Ltd.
Decision Date2021-01-08
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
OBS Anchorage Screw, Biokey Anchorage Screw is a medical device manufactured by Bomei Co, Ltd.. It received FDA 510(k) clearance on 2021-01-08 under approval number K202278. 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 OBS Anchorage Screw, Biokey Anchorage Screw?
OBS Anchorage Screw, Biokey Anchorage Screw is a medical device that received FDA 510(k) clearance on 2021-01-08. It is manufactured by Bomei Co, Ltd.. The 510(k) number is K202278.
When was OBS Anchorage Screw, Biokey Anchorage Screw approved by the FDA?
OBS Anchorage Screw, Biokey Anchorage Screw received FDA 510(k) clearance on 2021-01-08, under approval number K202278.
What company makes OBS Anchorage Screw, Biokey Anchorage Screw?
OBS Anchorage Screw, Biokey Anchorage Screw is manufactured by Bomei Co, Ltd..
What is the FDA product code for OBS Anchorage Screw, Biokey Anchorage Screw?
The FDA product code for OBS Anchorage Screw, Biokey Anchorage Screw is OAT.
Other Devices by Bomei Co, Ltd.
Related Devices (Code: OAT)
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.