The following data is part of a premarket notification filed by Choice Spine, Lp. with the FDA for Choice Spine Navigation System.
| Device ID | K182721 |
| 510k Number | K182721 |
| Device Name: | Choice Spine Navigation System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Choice Spine, LP. 400 Erin Drive Knoxville, TN 37919 |
| Contact | Kim Finch |
| Correspondent | Meredith Lee May Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-28 |
| Decision Date | 2019-01-08 |
| Summary: | summary |