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FDA 510(k)

FuseForce™ Flex Dynamic Compression System

K-Number: K203832 · 2021-05-07

ApplicantWright Medical
Decision Date2021-05-07
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FuseForce™ Flex Dynamic Compression System is the device name listed in this FDA 510(k) record. The listed applicant is Wright Medical. It received FDA 510(k) clearance on 2021-05-07 under 510(k) number K203832. 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 FuseForce™ Flex Dynamic Compression System?

FuseForce™ Flex Dynamic Compression System is a medical device that received FDA 510(k) clearance on 2021-05-07. The listed applicant is Wright Medical. The 510(k) number is K203832.

When did FuseForce™ Flex Dynamic Compression System receive FDA 510(k) clearance?

FuseForce™ Flex Dynamic Compression System received FDA 510(k) clearance on 2021-05-07, under 510(k) number K203832.

Who is the listed applicant for FuseForce™ Flex Dynamic Compression System?

The FDA 510(k) record lists Wright Medical as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FuseForce™ Flex Dynamic Compression System?

The FDA product code for FuseForce™ Flex Dynamic Compression System is JDR.

Other records listing Wright Medical as applicant

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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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.

K261121Megalodon Dynamic Compression SystemParagon 28, Inc.K250712Linkt Compression Staple SystemTrax SurgicalK243888Medline UNITE® REFLEX® Hybrid Nitinol Implant SystemMedline Industries, LPK243742Arthrex DynaNite Nitinol StaplesArthrex, Inc.K243658TMC Compression Implant SystemTreace Medical ConceptsK242415TMC Compression Implant SystemTreace Medical Concepts

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.

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