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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10840642104516 | K070245 | 000 |
| 10840642104325 | K070245 | 000 |
| 10840642104141 | K070245 | 000 |
| 10840642104134 | K070245 | 000 |
| 10840642104127 | K070245 | 000 |
| 10840642104110 | K070245 | 000 |
| 10840642104103 | K070245 | 000 |
| 10840642104097 | K070245 | 000 |
| 10840642104080 | K070245 | 000 |
| 10840642104073 | K070245 | 000 |
| 10840642104066 | K070245 | 000 |
| 10840642104059 | K070245 | 000 |
| 10840642104042 | K070245 | 000 |
| 10840642104035 | K070245 | 000 |
| 10840642104028 | K070245 | 000 |
| 10840642104011 | K070245 | 000 |
| 10840642104004 | K070245 | 000 |
| 10840642104332 | K070245 | 000 |
| 10840642104349 | K070245 | 000 |
| 10840642104509 | K070245 | 000 |
| 10840642104493 | K070245 | 000 |
| 10840642104486 | K070245 | 000 |
| 10840642104479 | K070245 | 000 |
| 10840642104462 | K070245 | 000 |
| 10840642104455 | K070245 | 000 |
| 10840642104448 | K070245 | 000 |
| 10840642104431 | K070245 | 000 |
| 10840642104424 | K070245 | 000 |
| 10840642104417 | K070245 | 000 |
| 10840642104400 | K070245 | 000 |
| 10840642104394 | K070245 | 000 |
| 10840642104387 | K070245 | 000 |
| 10840642104370 | K070245 | 000 |
| 10840642104363 | K070245 | 000 |
| 10840642104356 | K070245 | 000 |
| 10840642103991 | K070245 | 000 |