The following data is part of a premarket notification filed by Spinecraft Llc with the FDA for Apex-dl Spine System.
| Device ID | K143683 |
| 510k Number | K143683 |
| Device Name: | APEX-DL 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 | MNH |
| Subsequent Product Code | MNI |
| Subsequent Product Code | OSH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-24 |
| Decision Date | 2015-05-22 |
| Summary: | summary |