The following data is part of a premarket notification filed by Fusion Orthopedics, Llc with the FDA for Intralock System.
| Device ID | K210159 |
| 510k Number | K210159 |
| Device Name: | IntraLock System |
| Classification | Screw, Fixation, Bone |
| Applicant | Fusion Orthopedics, LLC 4135 S. Powder Rd., Suite 110 Mesa, AZ 85212 |
| Contact | Whitney Rey |
| Correspondent | Whitney Rey Fusion Orthopedics, LLC 4135 S. Powder 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 | 2021-01-21 |
| Decision Date | 2021-07-23 |