510(k) K051275 ยท NKB Thoracolumbosacral Pedicle Screw System
LAGUNA MONOAXIAL PEDICLE SCREW SYSTEM
| Applicant | Allez Spine, LLC, Cardiff CA, US |
| Decision | Substantially Equivalent, Dec 9, 2005 |
| Received | May 17, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051275
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2008 | Allez Spine, LLC Allez Spine Del Mar Pedicle Screw System; Catalog Number: IT-FN1001
Laguna Pedicle Screw System Tray #1; IT-FN 1002 Laguna Pedicle Screw System Tray #2; lT-CT1001Counter Torque (w/Large Rubber Handle) Terminated |
NKB | 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 Del Mar Pedicle Screw System: IT-FN 1007, Del Mar Sterilization Tray (Part Number: 30013) Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.