The following data is part of a premarket notification filed by Paradigm Spine with the FDA for Orthobiom Spinal System.
| Device ID | K071668 |
| 510k Number | K071668 |
| Device Name: | ORTHOBIOM SPINAL SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | PARADIGM SPINE 505 PARK AVE. 14TH FLOOR New York, NY 10022 |
| Contact | Marci Halevi |
| Correspondent | Marci Halevi PARADIGM SPINE 505 PARK AVE. 14TH FLOOR New York, NY 10022 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-06-19 |
| Decision Date | 2008-07-02 |
| Summary: | summary |