The following data is part of a premarket notification filed by Orthohelix Surgical Designs, Inc. with the FDA for Intraosseous Fixation System.
| Device ID | K141004 |
| 510k Number | K141004 |
| Device Name: | INTRAOSSEOUS FIXATION SYSTEM |
| Classification | Pin, Fixation, Smooth |
| 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 | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-18 |
| Decision Date | 2014-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846832035670 | K141004 | 000 |
| 00846832035151 | K141004 | 000 |
| 00846832035175 | K141004 | 000 |
| 00846832035199 | K141004 | 000 |
| 00846832035540 | K141004 | 000 |
| 00846832035557 | K141004 | 000 |
| 00846832035588 | K141004 | 000 |
| 00846832035595 | K141004 | 000 |
| 00846832035663 | K141004 | 000 |
| 00846832035137 | K141004 | 000 |