510(k) K050060 ยท MNI Orthosis, Spinal Pedicle Fixation
LAGUNA PEDICLE SCREW SYSTEM
| Applicant | Allez Spine, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, May 4, 2005 |
| Received | Jan 11, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050060
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System; Catalog Number: IT-FN1003
Del Mar Pedicle Screw System; IT-ST1001Vertebrae Rotation Tool;
IT-H W1001Hex Wrench; IT-CB1001Coronal Bender-L; IT-CB1002 Coronal Be Terminated |
MNI | None listed |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 30mm, Non-winged, Catalog # LG-PR0530 Terminated |
MNI | None listed |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 35mm, Non-winged, Catalog # LG-PR0535 Terminated |
MNI | None listed |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 45mm, Non-winged, Catalog # LG-PR0545 Terminated |
MNI | None listed |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 30mm, Non-winged, Catalog # LG-PR0630 Terminated |
MNI | None listed |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 35mm, Non-winged, Catalog # LG-PR0635 Terminated |
MNI | None listed |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 40mm, Non-winged, Catalog # LG-PR0640 Terminated |
MNI | None listed |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 50mm, Non-winged, Catalog # LG-PR0650 Terminated |
MNI | None listed |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 35mm, Non-winged, Catalog # LG-PR0735 and Screw Size (diameter x length) 7 x 50mm, Non-winged, Catalog # LG-PR07 Terminated |
MNI | None listed |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 40mm, Non-winged, Catalog # LG-PR0740 Terminated |
MNI | None listed |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 45mm, Non-winged, Catalog # LG-PR0745 Terminated |
MNI | None listed |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 35mm, Winged, Catalog # LG-PW0535 Terminated |
MNI | None listed |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 40mm, Winged, Catalog # LG-PW0540 Terminated |
MNI | None listed |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 45mm, Winged, Catalog # LG-PW0545 Terminated |
MNI | None listed |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 35mm, Winged, Catalog # LG-PW0635 and Screw Size (diameter x length) 6 x 55mm, Winged, Catalog # LG-PW0655 Terminated |
MNI | None listed |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 40mm, Winged, Catalog # LG-PW0640 Terminated |
MNI | None listed |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 45mm, Winged, Catalog # LG-PW0645 Terminated |
MNI | None listed |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 35mm, Winged, Catalog # LG-PW0735 Terminated |
MNI | None listed |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 40mm, Winged, Catalog # LG-PW0740 Terminated |
MNI | None listed |
| Sep 17, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 45mm, Winged, Catalog # LG-PW0745 Terminated |
MNI | None listed |
| Sep 2, 2008 | Allez Spine, LLC Allez Spine Laguna Pedicle Screw System: IT-FN1001, Laguna Sterilization Tray # 1 (Part Number: 54003); IT-FN1002, Laguna Sterilization Tray # 2 (Part Number: 54004) Terminated |
MNI | None listed |
| Mar 11, 2008 | Allez Spine, LLC Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 35, Catalog Number LG-PR0835, Allez Spine, LLC., Irvine, CA Terminated |
MNI | None listed |
| Mar 11, 2008 | Allez Spine, LLC Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 40, Catalog Number LG-PR0840, Allez Spine, LLC., Irvine, CA Terminated |
MNI | None listed |
| Mar 11, 2008 | Allez Spine, LLC Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 45, Catalog Number LG-PR0845, Allez Spine, LLC., Irvine, CA Terminated |
MNI | None listed |
| Mar 11, 2008 | Allez Spine, LLC Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 50, Catalog Number LG-PR0850, Allez Spine, LLC., Irvine, CA Terminated |
MNI | None listed |
| Mar 11, 2008 | Allez Spine, LLC Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 55, Catalog Number LG-PR0855, Allez Spine, LLC., Irvine, CA Terminated |
MNI | None listed |
| Mar 11, 2008 | Allez Spine, LLC Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter x length) 8 x 80, Catalog Number LG-PR0880, Allez Spine, LLC., Irvine, CA Terminated |
MNI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.