The following data is part of a premarket notification filed by Spinefrontier, Inc. with the FDA for Pedfuse Pedicle Screw System.
| Device ID | K143377 |
| 510k Number | K143377 |
| Device Name: | PedFuse Pedicle Screw System |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | SPINEFRONTIER, INC. 500 CUMMINGS CENTER SUITE 3500 Beverly, MA 01915 |
| Contact | Manthan J Damani |
| Correspondent | Kenneth C Maxwell Empirical Testing Corp. 4628 Northpark Drive Colorado Springs, CO 80918 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-25 |
| Decision Date | 2015-02-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190361035374 | K143377 | 000 |