The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Capsure(r) Ps System.
| Device ID | K083353 |
| 510k Number | K083353 |
| Device Name: | CAPSURE(R) PS 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 | 2008-11-13 |
| Decision Date | 2008-12-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840642104783 | K083353 | 000 |
| 10840642104752 | K083353 | 000 |
| 10840642104738 | K083353 | 000 |
| 10840642104714 | K083353 | 000 |
| 10840642104691 | K083353 | 000 |
| 10840642104677 | K083353 | 000 |
| 10840642104653 | K083353 | 000 |