The following data is part of a premarket notification filed by Maxxion Medical, Llc / Baumer Sa with the FDA for Mlp Special Locking Bone Plate System.
| Device ID | K181843 |
| 510k Number | K181843 |
| Device Name: | MLP Special Locking Bone Plate System |
| Classification | Plate, Fixation, Bone |
| Applicant | Maxxion Medical, LLC / Baumer SA 201 S. Biscayne Blvd., Suite 1200 Miami, FL 33131 |
| Contact | Bruno Baumer |
| Correspondent | Larry Petersen Medical Products International 4241 Wildwood Landing North Charleston, SC 29420 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-11 |
| Decision Date | 2019-03-04 |