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FDA 510(k)

DePuy Synthes Hammertoe Continuous Compression Implant

K-Number: K191463 · 2020-02-26

ApplicantSynthes (USA) Products, LLC
Decision Date2020-02-26
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DePuy Synthes Hammertoe Continuous Compression Implant is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2020-02-26 under 510(k) number K191463. 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 DePuy Synthes Hammertoe Continuous Compression Implant?

DePuy Synthes Hammertoe Continuous Compression Implant is a medical device that received FDA 510(k) clearance on 2020-02-26. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K191463.

When did DePuy Synthes Hammertoe Continuous Compression Implant receive FDA 510(k) clearance?

DePuy Synthes Hammertoe Continuous Compression Implant received FDA 510(k) clearance on 2020-02-26, under 510(k) number K191463.

Who is the listed applicant for DePuy Synthes Hammertoe Continuous Compression Implant?

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

What is the FDA product code for DePuy Synthes Hammertoe Continuous Compression Implant?

The FDA product code for DePuy Synthes Hammertoe Continuous Compression Implant is JDR.

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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

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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