The following data is part of a premarket notification filed by Surgalign Spine Technologies with the FDA for Arai Surgical Navigation System.
| Device ID | K211254 |
| 510k Number | K211254 |
| Device Name: | ARAI Surgical Navigation System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Surgalign Spine Technologies 520 Lake Cook Road, Suite 315 Deerfield, IL 60015 |
| Contact | Cristian Luciano |
| Correspondent | Jeremy Markovich Surgalign Spine Technologies 520 Lake Cook Road, Suite 315 Deerfield, IL 60015 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-26 |
| Decision Date | 2022-01-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850028694688 | K211254 | 000 |
| 00850028694671 | K211254 | 000 |
| 00850028694664 | K211254 | 000 |
| 00850028694633 | K211254 | 000 |
| 00850028694237 | K211254 | 000 |