The following data is part of a premarket notification filed by Orthohelix Surgical Designs, Inc. with the FDA for Calcaneal Trauma System.
| Device ID | K061400 |
| 510k Number | K061400 |
| Device Name: | CALCANEAL TRAUMA SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | ORTHOHELIX SURGICAL DESIGNS, INC. 1815 WEST MARKET ST. SUITE 205 Akron, OH 44313 |
| Contact | Lee A Strnad |
| Correspondent | Lee A Strnad ORTHOHELIX SURGICAL DESIGNS, INC. 1815 WEST MARKET ST. SUITE 205 Akron, OH 44313 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-19 |
| Decision Date | 2006-06-29 |
| Summary: | summary |