The following data is part of a premarket notification filed by Endius, Inc. with the FDA for Tri-fix Spinal Fixation System.
| Device ID | K013403 |
| 510k Number | K013403 |
| Device Name: | TRI-FIX SPINAL FIXATION SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | ENDIUS, INC. 23 WEST BACON ST. Plainville, MA 02762 |
| Contact | Susan Finneran |
| Correspondent | Susan Finneran ENDIUS, INC. 23 WEST BACON ST. Plainville, MA 02762 |
| Product Code | MNI |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-10-15 |
| Decision Date | 2001-11-14 |
| Summary: | summary |