The following data is part of a premarket notification filed by Neurostructures, Inc. with the FDA for Palladian Lumbar Pedicle Screw System.
| Device ID | K143230 |
| 510k Number | K143230 |
| Device Name: | Palladian Lumbar Pedicle Screw System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Neurostructures, Inc. 16 Technology Dr. Suite 165 Irvine, CA 32918 |
| Contact | Moti Altarac |
| Correspondent | Meredith L May Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-10 |
| Decision Date | 2015-02-25 |
| Summary: | summary |