The following data is part of a premarket notification filed by Orthohelix Surgical Designs, Inc. with the FDA for Drlock Distal Radius Volar System.
| Device ID | K053182 |
| 510k Number | K053182 |
| Device Name: | DRLOCK DISTAL RADIUS VOLAR SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | ORTHOHELIX SURGICAL DESIGNS, INC. 5905 FAWN LANE Cleveland, OH 44141 |
| Contact | Edward A Kroll |
| Correspondent | Edward A Kroll ORTHOHELIX SURGICAL DESIGNS, INC. 5905 FAWN LANE Cleveland, OH 44141 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-14 |
| Decision Date | 2006-02-27 |
| Summary: | summary |