The following data is part of a premarket notification filed by Spinefrontier, Inc. with the FDA for Spinefrontier Pedfuse Pedicle Screw System.
| Device ID | K133153 |
| 510k Number | K133153 |
| Device Name: | SPINEFRONTIER PEDFUSE PEDICLE SCREW SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | SPINEFRONTIER, INC. 500 CUMMINGS CENTER SUITE 3500 Beverly, MA 01915 |
| Contact | Paul L Speidel |
| Correspondent | Paul L Speidel SPINEFRONTIER, INC. 500 CUMMINGS CENTER SUITE 3500 Beverly, MA 01915 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-17 |
| Decision Date | 2014-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00190361034452 | K133153 | 000 |
| 00190361034568 | K133153 | 000 |
| 00190361034575 | K133153 | 000 |
| 00190361034582 | K133153 | 000 |
| 00190361034599 | K133153 | 000 |
| 00190361034605 | K133153 | 000 |
| 00190361034612 | K133153 | 000 |
| 00190361034629 | K133153 | 000 |
| 00190361034636 | K133153 | 000 |
| 00190361034551 | K133153 | 000 |
| 00190361034544 | K133153 | 000 |
| 00190361034469 | K133153 | 000 |
| 00190361034476 | K133153 | 000 |
| 00190361034483 | K133153 | 000 |
| 00190361034490 | K133153 | 000 |
| 00190361034506 | K133153 | 000 |
| 00190361034513 | K133153 | 000 |
| 00190361034520 | K133153 | 000 |
| 00190361034537 | K133153 | 000 |
| 00190361034643 | K133153 | 000 |
| 00190361034650 | K133153 | 000 |
| 00190361034667 | K133153 | 000 |
| 00190361034773 | K133153 | 000 |
| 00190361034780 | K133153 | 000 |
| 00190361034797 | K133153 | 000 |
| 00190361034803 | K133153 | 000 |
| 00190361034810 | K133153 | 000 |
| 00190361034827 | K133153 | 000 |
| 00190361034834 | K133153 | 000 |
| 00190361034841 | K133153 | 000 |
| 00190361034766 | K133153 | 000 |
| 00190361034759 | K133153 | 000 |
| 00190361034674 | K133153 | 000 |
| 00190361034681 | K133153 | 000 |
| 00190361034698 | K133153 | 000 |
| 00190361034704 | K133153 | 000 |
| 00190361034711 | K133153 | 000 |
| 00190361034728 | K133153 | 000 |
| 00190361034735 | K133153 | 000 |
| 00190361034742 | K133153 | 000 |
| 00190361034858 | K133153 | 000 |