The following data is part of a premarket notification filed by Fusion Orthopedics, Llc with the FDA for Intralock Lapidus System.
| Device ID | K182342 |
| 510k Number | K182342 |
| Device Name: | IntraLock Lapidus System |
| Classification | Screw, Fixation, Bone |
| Applicant | Fusion Orthopedics, LLC 4135 S. Power Rd., Suite 110 Mesa, AZ 85212 |
| Contact | Eli Jacobson |
| Correspondent | Eli Jacobson Fusion Orthopedics, LLC 4135 S. Power Rd., Suite 110 Mesa, AZ 85212 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-28 |
| Decision Date | 2019-05-21 |