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FDA 510(k)

OBS Anchorage Screw

K-Number: K152297 · 2016-02-09

Decision Date2016-02-09
Product CodeOAT
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OBS Anchorage Screw is a medical device manufactured by Bomei Co, Ltd.. It received FDA 510(k) clearance on 2016-02-09 under approval number K152297. 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?

OBS Anchorage Screw is a medical device that received FDA 510(k) clearance on 2016-02-09. It is manufactured by Bomei Co, Ltd.. The 510(k) number is K152297.

When was OBS Anchorage Screw approved by the FDA?

OBS Anchorage Screw received FDA 510(k) clearance on 2016-02-09, under approval number K152297.

What company makes OBS Anchorage Screw?

OBS Anchorage Screw is manufactured by Bomei Co, Ltd..

What is the FDA product code for OBS Anchorage Screw?

The FDA product code for OBS Anchorage Screw is OAT.

Other Devices by Bomei Co, Ltd.

Related Devices (Code: OAT)

Official Source

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