The following data is part of a premarket notification filed by Synthes (usa) Products, Llc with the FDA for Depuy Synthes 2.4mm Ti Self-tapping Matrixmandible Screws (26-40mm).
| Device ID | K201944 |
| 510k Number | K201944 |
| Device Name: | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) |
| Classification | Plate, Bone |
| Applicant | Synthes (USA) Products, LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Prem Pisupati |
| Correspondent | Prem Pisupati Synthes (USA) Products, LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-13 |
| Decision Date | 2020-09-10 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10887587075945 | K201944 | 000 |
| 10887587075853 | K201944 | 000 |
| 10887587075860 | K201944 | 000 |
| 10887587075877 | K201944 | 000 |
| 10887587075884 | K201944 | 000 |
| 10887587075891 | K201944 | 000 |
| 10887587075907 | K201944 | 000 |
| 10887587075914 | K201944 | 000 |
| 10887587075921 | K201944 | 000 |
| 10887587075938 | K201944 | 000 |
| 10887587075846 | K201944 | 000 |