The following data is part of a premarket notification filed by Spinecraft, Llc with the FDA for Astra Spine System.
| Device ID | K211323 |
| 510k Number | K211323 |
| Device Name: | ASTRA Spine System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | SpineCraft, LLC 777 Oakmont Lane, Suite 200 Westmont, IL 60559 |
| Contact | Ami Akallal-asaad |
| Correspondent | Ami Akallal-asaad SpineCraft, LLC 777 Oakmont Lane, Suite 200 Westmont, IL 60559 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| Subsequent Product Code | KWQ |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-30 |
| Decision Date | 2021-06-03 |