FDA.reportPublic FDA data

Spinal bone screw, non-bioabsorbable

Definition
A small, threaded, implantable rod with a screw head and drive intended for internal spinal fixation by being screwed into the spine to hold a correction/stabilization device (e.g., rod, plate, tether) to bone; it is made of a material that is not chemically degraded or absorbed via natural body processes (e.g., surgical steel, titanium alloy, carbon fibre). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used to provide immobilization and stabilization of spinal segments in the treatment of spinal instabilities or deformities. A screw head adaptor intended to stabilize a rod may be included with the screw.
GUDID devices
47,357
Last updated
2026-11-01 02:55:43

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840606175203PrimusSPINAL ELEMENTS, INC.66656-0002026-10-22
00840606185868PrimusSPINAL ELEMENTS, INC.66675-0102026-10-22
10705034442280EXPEDIUM VERSE™ SPINE SYSTEMMedos International Sàrl1997216402015-09-24
10705034442587EXPEDIUM VERSE™ SPINE SYSTEMMedos International Sàrl1997214602015-09-24
00763000750053CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.557510245402026-10-16
00763000750251CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.557510255302026-10-16
00763000750268CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.557510255352026-10-16
00763000750275CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.557510255402026-10-16
00763000750374CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.557510265352026-10-16
00763000750404CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.557510265502026-10-16
00763000786458CD HORIZON® Fenestrated Screw Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.65411012026-10-15
00810216329235ZSAlign Cervical Interbody System-ScrewZsfab, Inc.ZSAC06350142026-10-14
00810216329242ZSAlign Cervical Interbody System-ScrewZsfab, Inc.ZSAC06350162026-10-14
00810216329259ZSAlign Cervical Interbody System-ScrewZsfab, Inc.ZSAC06350182026-10-14
00810216329266ZSAlign Cervical Interbody System-ScrewZsfab, Inc.ZSAC06350202026-10-14
00810216329273ZSAlign Cervical Interbody System-ScrewZsfab, Inc.ZSAC06400122026-10-14
00810216329280ZSAlign Cervical Interbody System-ScrewZsfab, Inc.ZSAC06400142026-10-14
00810216329297ZSAlign Cervical Interbody System-ScrewZsfab, Inc.ZSAC06400162026-10-14
00810216329303ZSAlign Cervical Interbody System-ScrewZsfab, Inc.ZSAC06400182026-10-14
00810216329310ZSAlign Cervical Interbody System-ScrewZsfab, Inc.ZSAC06400202026-10-14
00810216329334ZSAlign Cervical Interbody System-ScrewZsfab, Inc.ZSAC07350142026-10-14
00810216329341ZSAlign Cervical Interbody System-ScrewZsfab, Inc.ZSAC07350162026-10-14
00810216329358ZSAlign Cervical Interbody System-ScrewZsfab, Inc.ZSAC07350182026-10-14
00810216329372ZSAlign Cervical Interbody System-ScrewZsfab, Inc.ZSAC07400122026-10-14
00810216329389ZSAlign Cervical Interbody System-ScrewZsfab, Inc.ZSAC07400142026-10-14
00810216329396ZSAlign Cervical Interbody System-ScrewZsfab, Inc.ZSAC07400162026-10-14
00810216329402ZSAlign Cervical Interbody System-ScrewZsfab, Inc.ZSAC07400182026-10-14
00810216329419ZSAlign Cervical Interbody System-ScrewZsfab, Inc.ZSAC07400202026-10-14
M697X073825100DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.X073-825100-DL2026-10-14
M697X07382560DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.X073-82560-DL2026-10-14
M697X07382565DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.X073-82565-DL2026-10-14
M697X07382570DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.X073-82570-DL2026-10-14
M697X07382575DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.X073-82575-DL2026-10-14
M697X07382580DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.X073-82580-DL2026-10-14
M697X07382585DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.X073-82585-DL2026-10-14
M697X07382590DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.X073-82590-DL2026-10-14
M697X07382595DL1Xpress Minimally Invasive Pedicle Screw SystemXtant Medical Holdings, Inc.X073-82595-DL2026-10-14
00763000990695INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC MINIMED, INC.36503152026-03-22
04250337106531Percusys® PlusJoimax GmbHJMPP0535PS2020-01-03
00763000874209MSB SHILLA Growth Guidance SystemMEDTRONIC SOFAMOR DANEK, INC.76745002026-10-11
10889981214395MeridianSeaspine Orthopedics CorporationRA1-0055152020-12-30
10889981214401MeridianSeaspine Orthopedics CorporationRA1-0055202020-12-30
10889981214418MeridianSeaspine Orthopedics CorporationRA1-0055252020-12-30
10889981214425MeridianSeaspine Orthopedics CorporationRA1-0055302020-12-30
10889981214432MeridianSeaspine Orthopedics CorporationRA1-0055352020-12-30
10889981214449MeridianSeaspine Orthopedics CorporationRA1-0060152020-12-30
10889981214456MeridianSeaspine Orthopedics CorporationRA1-0060202020-12-30
10889981214463MeridianSeaspine Orthopedics CorporationRA1-0060252020-12-30
10889981214470MeridianSeaspine Orthopedics CorporationRA1-0060302020-12-30
10889981214487MeridianSeaspine Orthopedics CorporationRA1-0060352020-12-30
10889981214746MeridianSeaspine Orthopedics CorporationRA1-1055202020-12-30
10889981214753MeridianSeaspine Orthopedics CorporationRA1-1055252020-12-30
10889981214760MeridianSeaspine Orthopedics CorporationRA1-1055302020-12-30
10889981214777MeridianSeaspine Orthopedics CorporationRA1-1055352020-12-30
10889981214784MeridianSeaspine Orthopedics CorporationRA1-1060202020-12-30
10889981214791MeridianSeaspine Orthopedics CorporationRA1-1060252020-12-30
10889981214807MeridianSeaspine Orthopedics CorporationRA1-1060302020-12-30
10889981214814MeridianSeaspine Orthopedics CorporationRA1-1060352020-12-30
10889981231392MeridianSeaspine Orthopedics CorporationRA1-0055402020-12-30
10889981231408MeridianSeaspine Orthopedics CorporationRA1-0055452020-12-30
10889981231415MeridianSeaspine Orthopedics CorporationRA1-0055502020-12-30
10889981231422MeridianSeaspine Orthopedics CorporationRA1-0055552020-12-30
10889981231439MeridianSeaspine Orthopedics CorporationRA1-0055602020-12-30
10889981231446MeridianSeaspine Orthopedics CorporationRA1-0055652020-12-30
10889981231453MeridianSeaspine Orthopedics CorporationRA1-0060402020-12-30
10889981231460MeridianSeaspine Orthopedics CorporationRA1-0060452020-12-30
10889981231477MeridianSeaspine Orthopedics CorporationRA1-0060502020-12-30
10889981231484MeridianSeaspine Orthopedics CorporationRA1-0060552020-12-30
10889981231491MeridianSeaspine Orthopedics CorporationRA1-0060602020-12-30
10889981231507MeridianSeaspine Orthopedics CorporationRA1-0060652020-12-30
10889981231514MeridianSeaspine Orthopedics CorporationRA1-1055402020-12-30
10889981231521MeridianSeaspine Orthopedics CorporationRA1-1055452020-12-30
10889981231538MeridianSeaspine Orthopedics CorporationRA1-1055502020-12-30
10889981231545MeridianSeaspine Orthopedics CorporationRA1-1055552020-12-30
10889981231552MeridianSeaspine Orthopedics CorporationRA1-1055602020-12-30
10889981231569MeridianSeaspine Orthopedics CorporationRA1-1055652020-12-30
10889981231576MeridianSeaspine Orthopedics CorporationRA1-1060402020-12-30
10889981231583MeridianSeaspine Orthopedics CorporationRA1-1060452020-12-30
10889981231590MeridianSeaspine Orthopedics CorporationRA1-1060502020-12-30
10889981231606MeridianSeaspine Orthopedics CorporationRA1-1060552020-12-30