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 |