The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Spine Wave Navigated Instruments.
| Device ID | K181596 |
| 510k Number | K181596 |
| Device Name: | Spine Wave Navigated Instruments |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | Spine Wave, Inc. 3 Enterprise Drive, Suite 210 Shelton, CT 06484 |
| Contact | Amy Noccioli |
| Correspondent | Amy Noccioli Spine Wave, Inc. 3 Enterprise Drive, Suite 210 Shelton, CT 06484 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-18 |
| Decision Date | 2018-10-24 |
| Summary: | summary |