The following data is part of a premarket notification filed by Spinal Usa with the FDA for Reform Pedicle Screw System.
| Device ID | K131343 |
| 510k Number | K131343 |
| Device Name: | REFORM PEDICLE SCREW SYSTEM |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | SPINAL USA 4628 NORTHPARK DRIVE Colorado Springs, CO 80918 |
| Contact | Meredith May |
| Correspondent | Meredith May SPINAL USA 4628 NORTHPARK DRIVE Colorado Springs, CO 80918 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-09 |
| Decision Date | 2013-07-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815362027417 | K131343 | 000 |
| 00815362027400 | K131343 | 000 |
| 00815362027394 | K131343 | 000 |
| 00815362027387 | K131343 | 000 |
| 00815362027370 | K131343 | 000 |
| 00815362027363 | K131343 | 000 |