The following data is part of a premarket notification filed by Precision Spine, Inc. with the FDA for Precision Spine Navigation Instrumentation.
| Device ID | K181606 |
| 510k Number | K181606 |
| Device Name: | Precision Spine Navigation Instrumentation |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Precision Spine, Inc. 2050 Executive Drive Pearl, MS 39208 |
| Contact | Michael C. Dawson |
| Correspondent | Meredith May Empirical Consulting 4628 Northpark Dr 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 | 2018-06-19 |
| Decision Date | 2019-09-27 |
| Summary: | summary |