The following data is part of a premarket notification filed by Oak Tree Engineering, Llc. with the FDA for Fixxsure Anterior Lumbar Plate And Screw System.
| Device ID | K211932 |
| 510k Number | K211932 |
| Device Name: | Fixxsure 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 | 2021-06-22 |
| Decision Date | 2021-07-27 |