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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 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 2020-09-10 under 510(k) 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. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K201944.

When did DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) receive FDA 510(k) clearance?

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

Who is the listed applicant for DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)?

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 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.

Other records listing Synthes (USA) Products, LLC as applicant

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Related Devices (Code: 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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