The following data is part of a premarket notification filed by Orthalign, Inc with the FDA for Orthalign Plus System.
| Device ID | K140331 |
| 510k Number | K140331 |
| Device Name: | ORTHALIGN PLUS SYSTEM |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | ORTHALIGN, INC 120 COLUMBIA SUITE 500 Aliso Viejo, CA 92656 |
| Contact | David Vancelette |
| Correspondent | David Vancelette ORTHALIGN, INC 120 COLUMBIA SUITE 500 Aliso Viejo, CA 92656 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-10 |
| Decision Date | 2014-06-10 |
| Summary: | summary |