The following data is part of a premarket notification filed by Orthalign, Inc with the FDA for Kneealign System With Reference Sensor.
| Device ID | K093998 |
| 510k Number | K093998 |
| Device Name: | KNEEALIGN SYSTEM WITH REFERENCE SENSOR |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-28 |
| Decision Date | 2010-03-22 |
| Summary: | summary |