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 | K201578 |
| 510k Number | K201578 |
| 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 | 2020-06-11 |
| Decision Date | 2020-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10886982280848 | K201578 | 000 |
| 10886982280749 | K201578 | 000 |
| 10886982280756 | K201578 | 000 |
| 10886982280763 | K201578 | 000 |
| 10886982280770 | K201578 | 000 |
| 10886982280787 | K201578 | 000 |
| 10886982280794 | K201578 | 000 |
| 10886982280800 | K201578 | 000 |
| 10886982280817 | K201578 | 000 |
| 10886982280824 | K201578 | 000 |
| 10886982280831 | K201578 | 000 |
| 10886982280732 | K201578 | 000 |