The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Sniper Spine System.
| Device ID | K151813 |
| 510k Number | K151813 |
| Device Name: | Sniper Spine System |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | SPINE WAVE, INC. 3 ENTERPRISE DRIVE, SUITE 210 Shelton, CT 06484 |
| Contact | Ronald K Smith |
| Correspondent | Ronald K Smith SPINE WAVE, INC. 3 ENTERPRISE DRIVE, SUITE 210 Shelton, CT 06484 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-07-02 |
| Decision Date | 2015-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840642106237 | K151813 | 000 |