The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Modification To Capsure Ps System.
| Device ID | K100122 |
| 510k Number | K100122 |
| Device Name: | MODIFICATION TO CAPSURE PS SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | SPINE WAVE, INC. THREE ENTERPRISE DR. SUITE 210 Shelton, CT 06484 |
| Contact | Roaida Rizkallah |
| Correspondent | Roaida Rizkallah SPINE WAVE, INC. THREE ENTERPRISE DR. SUITE 210 Shelton, CT 06484 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-01-15 |
| Decision Date | 2010-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840642103984 | K100122 | 000 |
| 10840642103977 | K100122 | 000 |
| 10840642103960 | K100122 | 000 |