The following data is part of a premarket notification filed by Lanterna Medical Technologies with the FDA for Santis Pedicle Screw System.
| Device ID | K133063 |
| 510k Number | K133063 |
| Device Name: | SANTIS PEDICLE SCREW SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | LANTERNA MEDICAL TECHNOLOGIES 13540 GUILD AVE Apple Valley, MN 55124 |
| Contact | Rich Jansen, Pharm.d. |
| Correspondent | Rich Jansen, Pharm.d. LANTERNA MEDICAL TECHNOLOGIES 13540 GUILD AVE Apple Valley, MN 55124 |
| Product Code | NKB |
| 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 | 2013-09-27 |
| Decision Date | 2014-01-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810021380384 | K133063 | 000 |
| 00810021380186 | K133063 | 000 |
| 00810021380179 | K133063 | 000 |
| 00810021380162 | K133063 | 000 |
| 00810021380155 | K133063 | 000 |
| 00810021380148 | K133063 | 000 |
| 00810021380131 | K133063 | 000 |
| 00810021380124 | K133063 | 000 |
| 00810021380117 | K133063 | 000 |
| 00810021380100 | K133063 | 000 |
| 00810021380094 | K133063 | 000 |
| 00810021380087 | K133063 | 000 |
| 00810021380070 | K133063 | 000 |
| 00810021380063 | K133063 | 000 |
| 00810021380056 | K133063 | 000 |
| 00810021380049 | K133063 | 000 |
| 00810021380032 | K133063 | 000 |
| 00810021380025 | K133063 | 000 |
| 00810021380193 | K133063 | 000 |
| 00810021380209 | K133063 | 000 |
| 00810021380377 | K133063 | 000 |
| 00810021380360 | K133063 | 000 |
| 00810021380353 | K133063 | 000 |
| 00810021380346 | K133063 | 000 |
| 00810021380339 | K133063 | 000 |
| 00810021380322 | K133063 | 000 |
| 00810021380315 | K133063 | 000 |
| 00810021380308 | K133063 | 000 |
| 00810021380292 | K133063 | 000 |
| 00810021380285 | K133063 | 000 |
| 00810021380278 | K133063 | 000 |
| 00810021380261 | K133063 | 000 |
| 00810021380254 | K133063 | 000 |
| 00810021380247 | K133063 | 000 |
| 00810021380230 | K133063 | 000 |
| 00810021380223 | K133063 | 000 |
| 00810021380216 | K133063 | 000 |
| 00810021380018 | K133063 | 000 |