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FDA 510(k)

DynaBridge

K-Number: K181815 · 2018-10-15

ApplicantFusion Orthopedics, LLC
Decision Date2018-10-15
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DynaBridge is a medical device manufactured by Fusion Orthopedics, LLC. It received FDA 510(k) clearance on 2018-10-15 under approval number K181815. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DynaBridge?

DynaBridge is a medical device that received FDA 510(k) clearance on 2018-10-15. It is manufactured by Fusion Orthopedics, LLC. The 510(k) number is K181815.

When was DynaBridge approved by the FDA?

DynaBridge received FDA 510(k) clearance on 2018-10-15, under approval number K181815.

What company makes DynaBridge?

DynaBridge is manufactured by Fusion Orthopedics, LLC.

What is the FDA product code for DynaBridge?

The FDA product code for DynaBridge is JDR.

Other Devices by Fusion Orthopedics, LLC

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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.

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