The following data is part of a premarket notification filed by Valpo Orthopedic Technology, Inc. with the FDA for Adjust-right Fixation Devices.
| Device ID | K062734 |
| 510k Number | K062734 |
| Device Name: | ADJUST-RIGHT FIXATION DEVICES |
| Classification | Staple, Fixation, Bone |
| Applicant | VALPO ORTHOPEDIC TECHNOLOGY, INC. 4805 LAKERIDGE CT. Valparaiso, IN 46383 |
| Contact | Ron Clark |
| Correspondent | Ron Clark VALPO ORTHOPEDIC TECHNOLOGY, INC. 4805 LAKERIDGE CT. Valparaiso, IN 46383 |
| Product Code | JDR |
| Subsequent Product Code | HWC |
| Subsequent Product Code | MBI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-13 |
| Decision Date | 2006-11-22 |