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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 the device name listed in this FDA 510(k) record. The listed applicant is Fusion Orthopedics, LLC. It received FDA 510(k) clearance on 2018-10-15 under 510(k) 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. The listed applicant is Fusion Orthopedics, LLC. The 510(k) number is K181815.

When did DynaBridge receive FDA 510(k) clearance?

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

Who is the listed applicant for DynaBridge?

The FDA 510(k) record lists Fusion Orthopedics, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DynaBridge?

The FDA product code for DynaBridge is JDR.

Other records listing Fusion Orthopedics, LLC as applicant

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Related Devices (Code: JDR)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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