The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Capsure Ps (r) Spine System.
| Device ID | K081228 |
| 510k Number | K081228 |
| Device Name: | CAPSURE PS (R) SPINE SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | SPINE WAVE, INC. TWO ENTERPRISE DR. SUITE 302 Shelton, CT 06484 |
| Contact | Roaida Rizkallah |
| Correspondent | Roaida Rizkallah SPINE WAVE, INC. TWO ENTERPRISE DR. SUITE 302 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 | 2008-04-30 |
| Decision Date | 2008-05-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840642104929 | K081228 | 000 |
| 10840642105131 | K081228 | 000 |
| 10840642105117 | K081228 | 000 |
| 10840642105094 | K081228 | 000 |
| 10840642105049 | K081228 | 000 |
| 10840642105025 | K081228 | 000 |
| 10840642105001 | K081228 | 000 |
| 10840642104981 | K081228 | 000 |
| 10840642104967 | K081228 | 000 |
| 10840642105155 | K081228 | 000 |
| 10840642105179 | K081228 | 000 |
| 10840642104905 | K081228 | 000 |
| 10840642104882 | K081228 | 000 |
| 10840642104868 | K081228 | 000 |
| 10840642104844 | K081228 | 000 |
| 10840642104820 | K081228 | 000 |
| 10840642104806 | K081228 | 000 |
| 10840642105216 | K081228 | 000 |
| 10840642105193 | K081228 | 000 |
| 10840642104943 | K081228 | 000 |