The following data is part of a premarket notification filed by Orthohelix Surgical Designs, Inc. with the FDA for Intraosseous Fixation System.
| Device ID | K120165 |
| 510k Number | K120165 |
| Device Name: | INTRAOSSEOUS FIXATION SYSTEM |
| Classification | Pin, Fixation, Smooth |
| Applicant | ORTHOHELIX SURGICAL DESIGNS, INC. 1065 Medina Rd. SUITE 500 Medina, OH 44256 |
| Contact | Derek Lewis |
| Correspondent | Derek Lewis ORTHOHELIX SURGICAL DESIGNS, INC. 1065 Medina Rd. SUITE 500 Medina, OH 44256 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-19 |
| Decision Date | 2012-04-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846832035656 | K120165 | 000 |
| 00846832035649 | K120165 | 000 |
| 00846832035601 | K120165 | 000 |
| 00846832035571 | K120165 | 000 |
| 00846832035533 | K120165 | 000 |
| 00846832035526 | K120165 | 000 |
| 00846832035489 | K120165 | 000 |
| 00846832035472 | K120165 | 000 |
| 00846832035441 | K120165 | 000 |