The following data is part of a premarket notification filed by Orthalign, Inc. with the FDA for Orthalign Plus System.
| Device ID | K200642 |
| 510k Number | K200642 |
| Device Name: | OrthAlign Plus System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | OrthAlign, Inc. 120 Columbia, Suite 500 Aliso Viejo, CA 92656 |
| Contact | Karyl Haskell |
| Correspondent | Karyl Haskell OrthAlign, Inc. 120 Columbia, Suite 500 Aliso Viejo, CA 92656 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-11 |
| Decision Date | 2020-04-10 |