The following data is part of a premarket notification filed by Si-bone, Inc. with the FDA for Neuromonitoring Kit.
| Device ID | K161893 |
| 510k Number | K161893 |
| Device Name: | Neuromonitoring Kit |
| Classification | Neurosurgical Nerve Locator |
| Applicant | SI-BONE, INC. 3055 OLIN AVE, SUITE 2200 San Jose, CA 95128 |
| Contact | Roxanne Dubois |
| Correspondent | Roxanne Dubois SI-BONE, INC. 3055 OLIN AVE, SUITE 2200 San Jose, CA 95128 |
| Product Code | PDQ |
| CFR Regulation Number | 874.1820 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-11 |
| Decision Date | 2016-10-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00863604000049 | K161893 | 000 |