The following data is part of a premarket notification filed by Synthes (usa) Products, Llc with the FDA for Depuy Synthes Variable Angle Locking Patella Plating System.
| Device ID | K210408 |
| 510k Number | K210408 |
| Device Name: | DePuy Synthes Variable Angle Locking Patella Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | Synthes (USA) Products, LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Enrico Gindro |
| Correspondent | Enrico Gindro Synthes (USA) Products, LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-02-11 |
| Decision Date | 2021-04-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886982291943 | K210408 | 000 |
| 10886982291936 | K210408 | 000 |
| 10886982291929 | K210408 | 000 |
| 10886982291912 | K210408 | 000 |