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 |