The following data is part of a premarket notification filed by Flospine with the FDA for Flospine Pedicle Screw System.
| Device ID | K141850 |
| 510k Number | K141850 |
| Device Name: | FLOSPINE PEDICLE SCREW SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | FLOSPINE 11821 BRAMBLE COVE DRIVE Ft. Myers, FL 33905 |
| Contact | Rich Jansen |
| Correspondent | Rich Jansen FLOSPINE 11821 BRAMBLE COVE DRIVE Ft. Myers, FL 33905 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | OSH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-09 |
| Decision Date | 2014-10-27 |
| Summary: | summary |