The following data is part of a premarket notification filed by Accel Spine with the FDA for Dali Spinal Fixation System.
| Device ID | K121568 |
| 510k Number | K121568 |
| Device Name: | DALI SPINAL FIXATION SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | ACCEL SPINE 14850 Quorum Dr Ste 220 Dallas, TX 75254 |
| Contact | Daniel Chon |
| Correspondent | Daniel Chon ACCEL SPINE 14850 Quorum Dr Ste 220 Dallas, TX 75254 |
| 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 | 2012-05-29 |
| Decision Date | 2012-09-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841732128309 | K121568 | 000 |
| 00841732121362 | K121568 | 000 |
| 00841732121379 | K121568 | 000 |
| 00841732121386 | K121568 | 000 |
| 00841732142961 | K121568 | 000 |
| 00841732142978 | K121568 | 000 |
| 00841732142985 | K121568 | 000 |
| 00841732142992 | K121568 | 000 |
| 00841732143005 | K121568 | 000 |
| 00841732125209 | K121568 | 000 |
| 00841732128255 | K121568 | 000 |
| 00841732128286 | K121568 | 000 |
| 00841732128293 | K121568 | 000 |
| 00841732121355 | K121568 | 000 |