The following data is part of a premarket notification filed by Ortho Development Corp. with the FDA for Contour Spinal System.
| Device ID | K990986 |
| 510k Number | K990986 |
| Device Name: | CONTOUR SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | ORTHO DEVELOPMENT CORP. 106 WEST 12200 SOUTH Draper, UT 84020 |
| Contact | Carol Freasier |
| Correspondent | Carol Freasier ORTHO DEVELOPMENT CORP. 106 WEST 12200 SOUTH Draper, UT 84020 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-24 |
| Decision Date | 1999-10-14 |