Home GUDID M7391613585000 TowerLOX EXT Cannulated Polyaxial EXT Screw 8.5 x 100mm
Primary DI M7391613585000
Brand TowerLOX EXT Cannulated Polyaxial EXT Screw 8.5 x 100mm
Company CAPTIVA SPINE, INC.
Model 16135-8500
Device description TowerLOX EXT Cannulated Polyaxial EXT Screw 8.5 x 100mm
Published 2018-11-14
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Single use true Product Codes# Code, Name table Code Name NKB Thoracolumbosacral Pedicle Screw System
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class NKB Thoracolumbosacral Pedicle Screw System Orthopedic 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status M7391613585000 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Orthopaedic bone screw, non-bioabsorbable, non-sterile "A small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A ""lag screw"" can be any of these used to obtain compression. This device must be sterilized prior to use."
Sterilization Methods# Method table Method Moist Heat or Steam Sterilization
Regulatory Flags# DUNS number 836975784 Device count 1 Lot or batch true Sterilization required before use true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published M739131064012 Variable Screw, Self-Tapping, 4.0mm x 12mm 13106-4012 2015-10-30 M739131064014 Variable Screw, Self-Tapping, 4.0mm x 14mm 13106-4014 2015-10-30 M739131064016 Variable Screw, Self-Tapping, 4.0mm x 16mm 13106-4016 2015-10-30 M739131064018 Variable Screw, Self-Tapping, 4.0mm x 18mm 13106-4018 2015-10-30 M739131164012 Fixed Screw, Self-Tapping, 4.0mm x 12mm 13116-4012 2015-10-30 M739131164014 Fixed Screw, Self-Tapping, 4.0mm x 14mm 13116-4014 2015-10-30 M739131164016 Fixed Screw, Self-Tapping, 4.0mm x 16mm 13116-4016 2015-10-30 M739131164018 Fixed Screw, Self-Tapping, 4.0mm x 18mm 13116-4018 2015-10-30 M73924712832 Cross Connector, XSmall 2471-2832 2015-10-30 M73924713139 Cross Connector, Small 2471-3139 2015-10-30 M73924713752 Cross Connector, Medium 2471-3752 2015-10-30 M73924714963 Cross Connector, Medium-Large 2471-4963 2015-10-30 M73924714975 Cross Connector, Large 2471-4975 2015-10-30 M739CP30020 1-Level Cervical Plates, 20 mm CP30020 2015-10-30 M739CP300200 1-Level Cervical Plates, 20 mm CP30020 2017-08-11 M739CP30022 1-Level Cervical Plates, 22 mm CP30022 2015-08-28 M739CP300220 1-Level Cervical Plates, 22 mm CP30022 2017-08-11 M739CP30024 1-Level Cervical Plates, 24 mm CP30024 2015-08-28 M739CP300240 1-Level Cervical Plates, 24 mm CP30024 2017-08-11 M739CP30026 1-Level Cervical Plates, 26 mm CP30026 2015-08-28
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