The following data is part of a premarket notification filed by Quantum Orthopedics, Inc. with the FDA for Modification To: Quantum Vertebral Body Replacement.
| Device ID | K052641 |
| 510k Number | K052641 |
| Device Name: | MODIFICATION TO: QUANTUM VERTEBRAL BODY REPLACEMENT |
| Classification | Spinal Vertebral Body Replacement Device |
| 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 | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-26 |
| Decision Date | 2006-04-12 |
| Summary: | summary |