The following data is part of a premarket notification filed by Orthalign, Inc with the FDA for Orthoalign Plus System.
| Device ID | K130387 |
| 510k Number | K130387 |
| Device Name: | ORTHOALIGN PLUS SYSTEM |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | ORTHALIGN, INC 338 VISTA MADERA Newport Beach, CA 92660 |
| Contact | Amy Walters |
| Correspondent | Amy Walters ORTHALIGN, INC 338 VISTA MADERA Newport Beach, CA 92660 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-02-15 |
| Decision Date | 2013-11-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00858704006817 | K130387 | 000 |
| 00810832030522 | K130387 | 000 |
| 00810832030515 | K130387 | 000 |
| 00810832031239 | K130387 | 000 |
| 00810832030669 | K130387 | 000 |
| 00810832031383 | K130387 | 000 |
| 00810832031314 | K130387 | 000 |
| 00810832031369 | K130387 | 000 |
| 00810832031352 | K130387 | 000 |