The following data is part of a premarket notification filed by Endius, Inc. with the FDA for Endius Title 2 Polyaxial Spinal System.
| Device ID | K070367 |
| 510k Number | K070367 |
| Device Name: | ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | ENDIUS, INC. 23 WEST BACON ST. Plainville, MA 02762 |
| Contact | Christine Kuntz-nassif |
| Correspondent | Christine Kuntz-nassif ENDIUS, INC. 23 WEST BACON ST. Plainville, MA 02762 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| 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 | 2007-02-08 |
| Decision Date | 2007-04-12 |
| Summary: | summary |