The following data is part of a premarket notification filed by Endius, Inc. with the FDA for Endius Spinal Fixation System.
| Device ID | K014090 |
| 510k Number | K014090 |
| Device Name: | ENDIUS SPINAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | ENDIUS, INC. 23 WEST BACON ST. Plainville, MA 02762 |
| Contact | Gene Dipoto |
| Correspondent | Gene Dipoto ENDIUS, INC. 23 WEST BACON ST. Plainville, MA 02762 |
| Product Code | KWP |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-12-11 |
| Decision Date | 2002-03-11 |
| Summary: | summary |