510(k) K053182 ยท HRS Plate, Fixation, Bone
DRLOCK DISTAL RADIUS VOLAR SYSTEM
| Applicant | Orthohelix Surgical Designs, Inc., Cleveland OH, US |
| Decision | Substantially Equivalent, Feb 27, 2006 |
| Received | Nov 14, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053182
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2007 | OrthoHelix Surgical Designs Inc DRL System Trays comprised of DRLock Bone Fixation Plates, Pegs, and Screw Systems: Four Plate Styles include: Part Numbers: DRV-002-0L Fixed Short Left Plate, DRV-002-0R , Fixed Short Right Plate, D Terminated |
HRS | None listed |
| Jan 19, 2007 | OrthoHelix Surgical Designs Inc DRLock Volar Plate Screw System, Model #DVR-900. The product is a kit contained in an aluminum tray case that contains the following: IMPLANTS:
6 stainless steel plates (2-lefts, 2-rights, and 1-righ Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.