The following data is part of a premarket notification filed by Nexxt Spine Llc with the FDA for Inertia Pedicle Screw And Deformity Correxxion System.
Device ID | K153453 |
510k Number | K153453 |
Device Name: | Inertia Pedicle Screw And Deformity Correxxion System |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | NEXXT SPINE LLC 14425 BERGEN BLVD, SUITE B Noblesville, IN 46060 |
Contact | Andy Elsbury |
Correspondent | Karen E. Warden BACKROADS CONSULTING PO BOX 566 Chesterland, OH 44026 -2141 |
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 | 2015-11-30 |
Decision Date | 2016-04-26 |
Summary: | summary |