The following data is part of a premarket notification filed by Maxxion Medical, Llc with the FDA for Cannulated Screws.
| Device ID | K213614 |
| 510k Number | K213614 |
| Device Name: | Cannulated Screws |
| Classification | Screw, Fixation, Bone |
| Applicant | Maxxion Medical, LLC 201, South Biscayne Boulevard, Suite 1200 Miami, FL 33131 |
| Contact | Guilherme Esteves Pontes |
| Correspondent | Guilherme Esteves Pontes Maxxion Medical, LLC 201, South Biscayne Boulevard, Suite 1200 Miami, FL 33131 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-15 |
| Decision Date | 2022-08-03 |