The following data is part of a premarket notification filed by Orthohelix Surgical Designs, Inc. with the FDA for Orthohelix Staple System.
| Device ID | K142148 |
| 510k Number | K142148 |
| Device Name: | ORTHOHELIX STAPLE SYSTEM |
| Classification | Staple, 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 | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-05 |
| Decision Date | 2014-08-21 |
| Summary: | summary |