The following data is part of a premarket notification filed by Orthalign Inc with the FDA for Harvey(r) Surgical Assistant.
| Device ID | K200892 |
| 510k Number | K200892 |
| Device Name: | Harvey(R) Surgical Assistant |
| 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 | 2020-04-03 |
| Decision Date | 2020-06-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810832031222 | K200892 | 000 |
| 00810832031130 | K200892 | 000 |
| 00810832030980 | K200892 | 000 |
| 00810832030973 | K200892 | 000 |
| 00810832030966 | K200892 | 000 |
| 00810832031406 | K200892 | 000 |
| 00810832031444 | K200892 | 000 |
| 00810832031468 | K200892 | 000 |