The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Capsure(r) Ps System.
| Device ID | K122233 |
| 510k Number | K122233 |
| Device Name: | CAPSURE(R) PS SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | SPINE WAVE, INC. THREE ENTERPRISE DR. SUITE 210 Shelton, CT 06484 |
| Contact | Joseph Mercado |
| Correspondent | Joseph Mercado SPINE WAVE, INC. THREE ENTERPRISE DR. 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 | 2012-07-26 |
| Decision Date | 2012-10-11 |
| Summary: | summary |