The following data is part of a premarket notification filed by Exsomed Corporation with the FDA for Exsomed Wrist Plating System.
| Device ID | K192473 |
| 510k Number | K192473 |
| Device Name: | Exsomed Wrist Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | Exsomed Corporation 135 Columbia, Suite 201 Aliso Viejo, CA 92656 |
| Contact | Michael Zwolinski |
| Correspondent | Michael Zwolinski Exsomed Corporation 135 Columbia, Suite 201 Aliso Viejo, CA 92656 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-10 |
| Decision Date | 2019-12-03 |