The following data is part of a premarket notification filed by Clearview Orthopedic Development, Llc with the FDA for Leucadia Autolok™ Pedicle Screw System.
| Device ID | K182339 |
| 510k Number | K182339 |
| Device Name: | LEUCADIA AUTOLOK™ Pedicle Screw System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | ClearView Orthopedic Development, LLC 15550-D Rockfield Blvd Irvine, CA 92618 |
| Contact | Hartmut Loch |
| Correspondent | Hartmut Loch ClearView Orthopedic Development, LLC 15550-D Rockfield Blvd Irvine, CA 92618 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-28 |
| Decision Date | 2018-12-12 |
| Summary: | summary |