The following data is part of a premarket notification filed by Orthohelix Surgical Designs, Inc. with the FDA for Orthohelix Staple System.
| Device ID | K130832 |
| 510k Number | K130832 |
| Device Name: | ORTHOHELIX STAPLE SYSTEM |
| Classification | Staple, Fixation, Bone |
| Applicant | ORTHOHELIX SURGICAL DESIGNS, INC. 1065 MEDINA ROAD SUITE 500 Medina, OH 44256 |
| Contact | Brian Hockett |
| Correspondent | Brian Hockett ORTHOHELIX SURGICAL DESIGNS, INC. 1065 MEDINA ROAD SUITE 500 Medina, OH 44256 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-26 |
| Decision Date | 2013-08-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00846832058976 | K130832 | 000 |
| 00846832058785 | K130832 | 000 |
| 00846832058778 | K130832 | 000 |
| 00846832058761 | K130832 | 000 |
| 00846832058754 | K130832 | 000 |
| 00846832058747 | K130832 | 000 |
| 00846832058730 | K130832 | 000 |
| 00846832058723 | K130832 | 000 |
| 00846832058716 | K130832 | 000 |
| 00846832058709 | K130832 | 000 |
| 00846832058693 | K130832 | 000 |
| 00846832055302 | K130832 | 000 |
| 00846832055272 | K130832 | 000 |
| 00846832055227 | K130832 | 000 |
| 00846832055180 | K130832 | 000 |
| 00846832055159 | K130832 | 000 |
| 00846832055128 | K130832 | 000 |
| 00846832058792 | K130832 | 000 |
| 00846832058808 | K130832 | 000 |
| 00846832058969 | K130832 | 000 |
| 00846832058952 | K130832 | 000 |
| 00846832058945 | K130832 | 000 |
| 00846832058938 | K130832 | 000 |
| 00846832058921 | K130832 | 000 |
| 00846832058914 | K130832 | 000 |
| 00846832058907 | K130832 | 000 |
| 00846832058891 | K130832 | 000 |
| 00846832058884 | K130832 | 000 |
| 00846832058877 | K130832 | 000 |
| 00846832058860 | K130832 | 000 |
| 00846832058853 | K130832 | 000 |
| 00846832058846 | K130832 | 000 |
| 00846832058839 | K130832 | 000 |
| 00846832058822 | K130832 | 000 |
| 00846832058815 | K130832 | 000 |
| 00846832055098 | K130832 | 000 |