The following data is part of a premarket notification filed by Oak Tree Engineering, Llc. with the FDA for Oaktree Anterior Lumbar Plate And Screw System.
| Device ID | K220843 |
| 510k Number | K220843 |
| Device Name: | OAKTREE Anterior Lumbar Plate And Screw System |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | Oak Tree Engineering, LLC. 419 Main Street, #242 Huntington Beach, CA 92648 |
| Contact | Douglas W. Neary |
| Correspondent | Douglas W. Neary Consultant 419 Main Street, #242 Huntington Beach, CA 92648 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-23 |
| Decision Date | 2022-12-07 |