The following data is part of a premarket notification filed by Quantum Orthopedics, Inc. with the FDA for Quantum Anterior Cervical Plate System.
| Device ID | K060491 |
| 510k Number | K060491 |
| Device Name: | QUANTUM ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | QUANTUM ORTHOPEDICS, INC. 2744 LOKER AVE. W. SUITE 100 Carlsbad, CA 92008 |
| Contact | Jason Blain |
| Correspondent | Jason Blain QUANTUM ORTHOPEDICS, INC. 2744 LOKER AVE. W. SUITE 100 Carlsbad, CA 92008 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-24 |
| Decision Date | 2006-03-13 |
| Summary: | summary |