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FDA 510(k)

DePuy Synthes Hammertoe Continuous Compression Implant

K-Number: K191463 · 2020-02-26

Decision Date2020-02-26
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DePuy Synthes Hammertoe Continuous Compression Implant is a medical device manufactured by Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2020-02-26 under approval 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. It is manufactured by Synthes (USA) Products, LLC. The 510(k) number is K191463.

When was DePuy Synthes Hammertoe Continuous Compression Implant approved by the FDA?

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

What company makes DePuy Synthes Hammertoe Continuous Compression Implant?

DePuy Synthes Hammertoe Continuous Compression Implant is manufactured by Synthes (USA) Products, LLC.

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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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.