Atlas FDA

LAGUNA PEDICLE SCREW SYSTEM

FDA 510(k) clearance K050060 · decided 2005-05-04

Clearance details

K-number
K050060
Device name
LAGUNA PEDICLE SCREW SYSTEM
Applicant
Allez Spine, LLC
Decision
Substantially Equivalent
Date received
2005-01-11
Decision date
2005-05-04
Days to decision
113 days
Clearance type
Traditional
Product code
MNI
Device class
2
Regulation number
888.3070
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Irvine, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Allez Spine Laguna Pedicle Screw System; Catalog Number: IT-FN1003 Del Mar Pedicle Screw S recall (Z-0153-2009)Allez Spine, LLC2008-10-28
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 30 recall (Z-2060-2008)Allez Spine, LLC2008-09-17
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 35 recall (Z-2061-2008)Allez Spine, LLC2008-09-17
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 45 recall (Z-2062-2008)Allez Spine, LLC2008-09-17
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 30 recall (Z-2063-2008)Allez Spine, LLC2008-09-17
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 35 recall (Z-2064-2008)Allez Spine, LLC2008-09-17
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 40 recall (Z-2065-2008)Allez Spine, LLC2008-09-17
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 50 recall (Z-2066-2008)Allez Spine, LLC2008-09-17
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 35 recall (Z-2067-2008)Allez Spine, LLC2008-09-17
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 40 recall (Z-2068-2008)Allez Spine, LLC2008-09-17
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 45 recall (Z-2069-2008)Allez Spine, LLC2008-09-17
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 35 recall (Z-2070-2008)Allez Spine, LLC2008-09-17
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 40 recall (Z-2071-2008)Allez Spine, LLC2008-09-17
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 5 x 45 recall (Z-2072-2008)Allez Spine, LLC2008-09-17
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 35 recall (Z-2073-2008)Allez Spine, LLC2008-09-17
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 40 recall (Z-2074-2008)Allez Spine, LLC2008-09-17
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 6 x 45 recall (Z-2075-2008)Allez Spine, LLC2008-09-17
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 35 recall (Z-2076-2008)Allez Spine, LLC2008-09-17
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 40 recall (Z-2077-2008)Allez Spine, LLC2008-09-17
Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter x length) 7 x 45 recall (Z-2078-2008)Allez Spine, LLC2008-09-17
Allez Spine Laguna Pedicle Screw System: IT-FN1001, Laguna Sterilization Tray # 1 (Part Nu recall (Z-1819-2008)Allez Spine, LLC2008-09-02
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter recall (Z-0186-2008)Allez Spine, LLC2008-03-11
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter recall (Z-0187-2008)Allez Spine, LLC2008-03-11
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter recall (Z-0188-2008)Allez Spine, LLC2008-03-11
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter recall (Z-0189-2008)Allez Spine, LLC2008-03-11
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter recall (Z-0190-2008)Allez Spine, LLC2008-03-11
Size 8 Pedicle Screws of the Allez Spine Laguna Pedicle Screw System, Screw Size (diameter recall (Z-0191-2008)Allez Spine, LLC2008-03-11