The following data is part of a premarket notification filed by Eisertech, Llc with the FDA for Spinal System.
| Device ID | K142576 |
| 510k Number | K142576 |
| Device Name: | Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | EISERTECH, LLC 13795 Blaisdell Place, Suite 102 Poway, CA 92064 |
| Contact | Lukas Eisermann |
| Correspondent | Lukas Eisermann EISERTECH, LLC 13795 Blaisdell Place, Suite 102 Poway, CA 92064 |
| 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 | 2014-09-12 |
| Decision Date | 2015-02-26 |
| Summary: | summary |