Company ยท US
Allez Spine, LLC
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2009. Name variants (Inc, Corp, punctuation) are merged.
7510(k) clearances (0 in 12 months)
30recalls (0 in 12 months)
30recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 7, 2009 | K091995 | LAGUNA SIZE 8 PEDICLE SCREW SYSTEM Allez Spine, LLC | NKB |
| Jul 9, 2009 | K091219 | DEL MAR MONOAXIAL PEDICLE SCREW SYSTEM Allez Spine, LLC | NKB |
| Jan 22, 2009 | K083826 | LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM Allez Spine, LLC | MNH |
| Jul 2, 2008 | K072678 | LAGUNA SIZE 8 PEDICLE SCREW Allez Spine, LLC | NKB |
| Jun 11, 2007 | K070460 | ALLEZ SPINE CROSS CONNECTORS Allez Spine, LLC | NKB |
| Dec 9, 2005 | K051275 | LAGUNA MONOAXIAL PEDICLE SCREW SYSTEM Allez Spine, LLC | NKB |
| May 4, 2005 | K050060 | LAGUNA PEDICLE SCREW SYSTEM Allez Spine, LLC | MNI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2008 | Allez Spine, LLC Allez Spine Cross Connectors; Catalog Number: LG-CC1001Cross Link, Small 30-37mm; LG-CC1002 Cross Link, Medium 37-50mm; LG-CC1003
Cross Link, Lange 50-80mm; lT-T01003 Cross Link Torque Hex Driver, 2.5 Terminated |
NKB | K070460 |
| 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 | K051275 |
| 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 | K050060 |
| 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 | K050060 K051275 |
| 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 | K050060 K051275 |
| 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 | K050060 K051275 |
| 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 | K050060 K051275 |
| 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 | K050060 K051275 |
| 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 | K050060 K051275 |
| 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 | K050060 K051275 |
| 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 | K050060 K051275 |
| 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 | K050060 K051275 |
| 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 | K050060 K051275 |
| 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 | K050060 K051275 |
| 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 | K050060 K051275 |
| 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 | K050060 K051275 |
| 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 | K050060 K051275 |
| 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 | K050060 K051275 |
| 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 | K050060 K051275 |
| 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 | K050060 K051275 |
| 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 | K050060 K051275 |
| 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 | K050060 K051275 |
| 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 | K051275 |
| 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 | K050060 |
| 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 | K050060 |
| 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 | K050060 |
| 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 | K050060 |
| 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 | K050060 |
| 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 | K050060 |
| 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 | K050060 |