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 |