The following data is part of a premarket notification filed by Orthohelix Surgical Designs, Inc. with the FDA for Orthohelix Syndesmosis Fixation Devices.
| Device ID | K132733 |
| 510k Number | K132733 |
| Device Name: | ORTHOHELIX SYNDESMOSIS FIXATION DEVICES |
| Classification | Washer, Bolt Nut |
| 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 | HTN |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-03 |
| Decision Date | 2014-01-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846832056682 | K132733 | 000 |
| 00846832056651 | K132733 | 000 |