The following data is part of a premarket notification filed by Spinecraft Llc with the FDA for Astra-oct Spine System.
Device ID | K181350 |
510k Number | K181350 |
Device Name: | ASTRA-OCT Spine System |
Classification | Posterior Cervical 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 | NKG |
CFR Regulation Number | 888.3075 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-05-22 |
Decision Date | 2018-07-06 |