The following data is part of a premarket notification filed by Orthohelix Surgical Designs, Inc. with the FDA for Maxtorque Screw System.
| Device ID | K131324 |
| 510k Number | K131324 |
| Device Name: | MAXTORQUE SCREW SYSTEM |
| Classification | Screw, Fixation, Bone |
| Applicant | ORTHOHELIX SURGICAL DESIGNS, INC. 1065 Medina Rd. SUITE 500 Medina, OH 44256 |
| Contact | Brian Hockett |
| Correspondent | Brian Hockett ORTHOHELIX SURGICAL DESIGNS, INC. 1065 Medina Rd. SUITE 500 Medina, OH 44256 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-08 |
| Decision Date | 2013-05-31 |
| Summary: | summary |