The following data is part of a premarket notification filed by Choice Spine with the FDA for Choice Spine Hawkeye Vertebral Body Replacement (vbr) System.
| Device ID | K183588 |
| 510k Number | K183588 |
| Device Name: | Choice Spine Hawkeye Vertebral Body Replacement (VBR) System |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | Choice Spine 400 Erin Drive Knoxville, TN 37919 |
| Contact | Kim Finch |
| Correspondent | Kim Finch Choice Spine 400 Erin Drive Knoxville, TN 37919 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-21 |
| Decision Date | 2019-02-22 |
| Summary: | summary |