The following data is part of a premarket notification filed by Choicespine, Llc with the FDA for Choicespine Navigation System.
| Device ID | K220024 |
| 510k Number | K220024 |
| Device Name: | ChoiceSpine Navigation System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | ChoiceSpine, LLC 400 Erin Drive Knoxville, TN 37919 |
| Contact | Kim Finch |
| Correspondent | Kim Finch ChoiceSpine, LLC 400 Erin Drive Knoxville, TN 37919 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-01-05 |
| Decision Date | 2022-07-06 |