The following data is part of a premarket notification filed by Orthocircle Spine with the FDA for Orthocircle Spine Pedicle Screw System.
| Device ID | K193472 |
| 510k Number | K193472 |
| Device Name: | OrthoCircle Spine Pedicle Screw System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | OrthoCircle Spine 15 East Montgomery Crossroads. Suite 3 Savannah, GA 31406 |
| Contact | Jack Mathews |
| Correspondent | Nathan Wright Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-16 |
| Decision Date | 2020-02-13 |