The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for Ibis Pedicle Screw System.
| Device ID | K142146 |
| 510k Number | K142146 |
| Device Name: | IBIS PEDICLE SCREW SYSTEM |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | ORTHO DEVELOPMENT CORP. 12187 SOUTH BUSINESS PARK DR. Draper, UT 84020 |
| Contact | Mike Ensign |
| Correspondent | Mike Ensign ORTHO DEVELOPMENT CORP. 12187 SOUTH BUSINESS PARK DR. Draper, UT 84020 |
| 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 | 2014-08-05 |
| Decision Date | 2014-12-11 |
| Summary: | summary |