The following data is part of a premarket notification filed by Spinecraft Llc with the FDA for Apex Spine System.
Device ID | K132603 |
510k Number | K132603 |
Device Name: | APEX SPINE SYSTEM |
Classification | Thoracolumbosacral Pedicle Screw System |
Applicant | SPINECRAFT LLC 777 OAKMONT LANE Westmont, IL 60559 |
Contact | Ami Akallal-asaad |
Correspondent | Ami Akallal-asaad SPINECRAFT LLC 777 OAKMONT LANE Westmont, IL 60559 |
Product Code | NKB |
Subsequent Product Code | KWP |
Subsequent Product Code | KWQ |
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 | 2013-08-20 |
Decision Date | 2013-11-20 |
Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
APEX SPINE SYSTEM 85820194 not registered Dead/Abandoned |
SpineCraft, LLC 2013-01-10 |