The following data is part of a premarket notification filed by Arthro-dif with the FDA for Acrosspine Pedicle Screw System.
| Device ID | K141695 |
| 510k Number | K141695 |
| Device Name: | ACROSSPINE PEDICLE SCREW SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | ARTHRO-DIF 11821 BRAMBLE COVE DRIVE Ft.myers, FL 33905 |
| Contact | Rich Jansen |
| Correspondent | Rich Jansen ARTHRO-DIF 11821 BRAMBLE COVE DRIVE Ft.myers, FL 33905 |
| Product Code | NKB |
| 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 | 2014-06-24 |
| Decision Date | 2014-12-30 |
| Summary: | summary |