The following data is part of a premarket notification filed by Next Orthosurgical with the FDA for Vertiform Posterior Fixation System.
Device ID | K141291 |
510k Number | K141291 |
Device Name: | VERTIFORM POSTERIOR FIXATION SYSTEM |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | NEXT ORTHOSURGICAL 3270 Corporate Vw Ste A Vista, CA 92081 |
Contact | Huan Tran |
Correspondent | Huan Tran NEXT ORTHOSURGICAL 3270 Corporate Vw Ste A Vista, CA 92081 |
Product Code | NKB |
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 | 2014-05-19 |
Decision Date | 2014-08-26 |
Summary: | summary |