The following data is part of a premarket notification filed by Precision Spine with the FDA for Reform Pedicle Screw System.
| Device ID | K200303 |
| 510k Number | K200303 |
| Device Name: | Reform Pedicle Screw System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | Precision Spine 2050 Executive Drive Pearl, MS 39208 |
| Contact | Micheal C. Dawson |
| Correspondent | John D. Webb The OrthoMedix Group, Inc. 4313 W. 3800 S. West Haven, UT 84401 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-02-06 |
| Decision Date | 2020-05-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840019967563 | K200303 | 000 |
| 00840019967471 | K200303 | 000 |
| 00840019967488 | K200303 | 000 |
| 00840019967495 | K200303 | 000 |
| 00840019967501 | K200303 | 000 |
| 00840019967518 | K200303 | 000 |
| 00840019967525 | K200303 | 000 |
| 00840019967532 | K200303 | 000 |
| 00840019967549 | K200303 | 000 |
| 00840019967464 | K200303 | 000 |