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FDA 510(k)

DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)

K-Number: K201944 · 2020-09-10

ApplicantSynthes (USA) Products, LLC
Decision Date2020-09-10
Product CodeJEY
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) is a medical device manufactured by Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2020-09-10 under approval number K201944. The device is classified under product code JEY. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)?

DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) is a medical device that received FDA 510(k) clearance on 2020-09-10. It is manufactured by Synthes (USA) Products, LLC. The 510(k) number is K201944.

When was DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) approved by the FDA?

DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) received FDA 510(k) clearance on 2020-09-10, under approval number K201944.

What company makes DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)?

DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) is manufactured by Synthes (USA) Products, LLC.

What is the FDA product code for DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)?

The FDA product code for DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) is JEY.

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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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