DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)
FDA 510(k) K201944 · Synthes (USA) Products, LLC
510(k) numberK201944
Submission
- Device name
- DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm)
- Applicant
- Synthes (USA) Products, LLC
West Chester, PA, US - Received
- July 13, 2020
- Decision date
- September 10, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) cleared by the FDA?
DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) (K201944) received a 510(k) decision of Substantially Equivalent on September 10, 2020, 59 days after the submission was received.
What is the product code of K201944?
The FDA product code is JEY – Plate, Bone, a Class II (moderate risk) device regulated under 21 CFR 872.4760.