The following data is part of a premarket notification filed by Choice Spine, Lp with the FDA for Choice Spine Laminoplasty™ Fixation System.
| Device ID | K173215 |
| 510k Number | K173215 |
| Device Name: | Choice Spine Laminoplasty™ Fixation System |
| Classification | Orthosis, Spine, Plate, Laminoplasty, Metal |
| Applicant | Choice Spine, LP 400 Erin Drive Knoxville, TN 37919 |
| Contact | Kim Finch |
| Correspondent | Kim Finch Choice Spine, LP 400 Erin Drive Knoxville, TN 37919 |
| Product Code | NQW |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-02 |
| Decision Date | 2018-01-19 |
| Summary: | summary |