FDA 510(k)

OsteoBridge IDSF System

K-Number: K181026 · 2018-10-17

Decision Date2018-10-17

Product CodeHSB

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

OsteoBridge IDSF System is a medical device manufactured by Merete GmbH. It received FDA 510(k) clearance on 2018-10-17 under approval number K181026. The device is classified under product code HSB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OsteoBridge IDSF System?

OsteoBridge IDSF System is a medical device that received FDA 510(k) clearance on 2018-10-17. It is manufactured by Merete GmbH. The 510(k) number is K181026.

When was OsteoBridge IDSF System approved by the FDA?

OsteoBridge IDSF System received FDA 510(k) clearance on 2018-10-17, under approval number K181026.

What company makes OsteoBridge IDSF System?

OsteoBridge IDSF System is manufactured by Merete GmbH.

What is the FDA product code for OsteoBridge IDSF System?

The FDA product code for OsteoBridge IDSF System is HSB.

Other Devices by Merete GmbH

K172213MECRON Cannulated Screw System

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.