The following data is part of a premarket notification filed by Orthalign, Inc. with the FDA for Kneealign 2 System.
| Device ID | K163379 |
| 510k Number | K163379 |
| Device Name: | KneeAlign 2 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 | 2016-12-01 |
| Decision Date | 2017-03-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810832031123 | K163379 | 000 |