The following data is part of a premarket notification filed by Spine Wave, Inc. with the FDA for Capsure Pedicle Screw System.
| Device ID | K070245 |
| 510k Number | K070245 |
| Device Name: | CAPSURE PEDICLE SCREW SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | SPINE WAVE, INC. TWO ENTERPRISE DR. SUITE 302 Shelton, CT 06484 |
| Contact | Ronald K Smith |
| Correspondent | Ronald K Smith SPINE WAVE, INC. TWO ENTERPRISE DR. SUITE 302 Shelton, CT 06484 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-25 |
| Decision Date | 2007-04-05 |
| Summary: | summary |