The following data is part of a premarket notification filed by Spinecraft Llc with the FDA for Astra Spine System.
Device ID | K150417 |
510k Number | K150417 |
Device Name: | ASTRA 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 | 2015-02-18 |
Decision Date | 2015-05-19 |
Summary: | summary |