The following data is part of a premarket notification filed by Senecka Spine with the FDA for Seneka Ii Polyscrew Pedicle Fixation System.
| Device ID | K153525 |
| 510k Number | K153525 |
| Device Name: | Seneka II Polyscrew Pedicle Fixation System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Senecka Spine 46 Harrison Street Johnson City, NY 13790 |
| Contact | Khalid Sethi |
| Correspondent | Rich Jansen SILVER PINE CONSULTING, LLC. 11821 BRAMBLE COVE DRIVE Fort Myers, FL 33905 |
| 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 | 2015-12-09 |
| Decision Date | 2016-01-28 |