The following data is part of a premarket notification filed by Lanterna Medical Technologies with the FDA for Santis Pedicle Screw System.
| Device ID | K150507 |
| 510k Number | K150507 |
| Device Name: | Santis Pedicle Screw System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | LANTERNA MEDICAL TECHNOLOGIES 294 RORSCHACHERSTRASSE St.gallen, CH 9016 |
| Contact | Horace Hale |
| Correspondent | Rich Jansen SILVER PINE CONSULTING, LLC. 11821 BRAMBLE COVE DRIVE Ft. Myers, FL 33905 |
| Product Code | NKB |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-26 |
| Decision Date | 2015-04-03 |
| Summary: | summary |