FDA.reportPublic FDA data

Bone-screw internal spinal fixation system rod

Definition
An implantable component of a bone-screw internal spinal fixation system in the form of a thin cylinder intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, and also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. This component is designed as a longitudinal (intervertebral) connecting element passing through the system’s implantable screw heads or hooks. It is available in various forms (e.g., straight, curved, rigid, flexible, with varying diameters); flexible types may allow small movements of the spine.
GUDID devices
19,110
Last updated
2026-11-02 18:09:46

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
03701313009632KHEIRONS.M.A.I.O34KR550002026-10-23
03701313009649KHEIRONS.M.A.I.O34KR600002026-10-23
03701313009656KHEIRONS.M.A.I.O34SR606002026-10-23
03701313009663KHEIRONS.M.A.I.O34SR604002026-10-23
03701313009670KHEIRONS.M.A.I.O34SR556002026-10-23
03701313009687KHEIRONS.M.A.I.O34SR554002026-10-23
03701313009694KHEIRONS.M.A.I.O34CR609552026-10-23
03701313009700KHEIRONS.M.A.I.O34CR609452026-10-23
03701313009717KHEIRONS.M.A.I.O34CR606552026-10-23
03701313009724KHEIRONS.M.A.I.O34CR606452026-10-23
03701313009731KHEIRONS.M.A.I.O34CR604552026-10-23
03701313009748KHEIRONS.M.A.I.O34CR604452026-10-23
03701313009755KHEIRONS.M.A.I.O34CR559552026-10-23
03701313009762KHEIRONS.M.A.I.O34CR559452026-10-23
03701313009779KHEIRONS.M.A.I.O34CR556552026-10-23
03701313009786KHEIRONS.M.A.I.O34CR556452026-10-23
03701313009793KHEIRONS.M.A.I.O34CR554552026-10-23
03701313009809KHEIRONS.M.A.I.O34CR554452026-10-23
03701313010027KHEIRONS.M.A.I.O34SR555052026-10-23
03701313010034KHEIRONS.M.A.I.O34SR605052026-10-23
00840466901011PrimusSPINAL ELEMENTS, INC.66027-0452026-10-22
03701313009823KHEIRONS.M.A.I.O34KR600042026-10-22
03701313009830KHEIRONS.M.A.I.O34KR600032026-10-22
03701313009854KHEIRONS.M.A.I.O34KR600012026-10-22
03701313009878KHEIRONS.M.A.I.O34KR550042026-10-22
03701313009885KHEIRONS.M.A.I.O34KR550032026-10-22
03701313009892KHEIRONS.M.A.I.O34KR550022026-10-22
03701313009908KHEIRONS.M.A.I.O34KR550012026-10-22
03701313009618KHEIRONS.M.A.I.O30KR550022026-09-23
07290014064546VersaLink™ Ring NutPREMIA SPINE LTD825832026-10-18
07290014064553VersaLink™ Ring Set ScrewPREMIA SPINE LTD825822026-10-18
07290014064560VersaLink™ CrossbarPREMIA SPINE LTD826102026-10-18
07290014064959VersaLink™ Ring Set Screw TorxPREMIA SPINE LTD865052026-10-18
07290014080126Fusion Rod 50mmPREMIA SPINE LTD831962026-10-18
07290014080133Fusion Rod 70mmPREMIA SPINE LTD831972026-10-18
07290014080140Fusion Rod 90mmPREMIA SPINE LTD831982026-10-18
07290115932461PER Ring NutPREMIA SPINE LTD884972026-10-18
07290115932478PER Set Screw TorxPREMIA SPINE LTD884982026-10-18
00840916108069OMNISPINAL ELEMENTSLCPT 45-K2017-06-28
00840916108076OMNISPINAL ELEMENTSLCPT 50-K2017-06-28
00840916108083OMNISPINAL ELEMENTSLCPT 55-K2017-06-28
00840916108090OMNISPINAL ELEMENTSLCPT 60-K2017-06-28
00840916108106OMNISPINAL ELEMENTSLCPT 65-K2017-06-28
00840916108113OMNISPINAL ELEMENTSLCPT 70-K2017-06-28
00840916108120OMNISPINAL ELEMENTSLCPT 75-K2017-06-28
00840916108137OMNISPINAL ELEMENTSLCPT 80-K2017-06-28
00840916108144OMNISPINAL ELEMENTSLCPT 90-K2017-06-28
00840916108335OMNISPINAL ELEMENTSLCT3002017-06-19
00840916108434OMNISPINAL ELEMENTSLCT502017-06-27
00840916108502OMNISPINAL ELEMENTSLCT50-F-C2017-06-27
00840916108700OMNISPINAL ELEMENTSLCT70452017-06-27
00840916109837TALONSPINAL ELEMENTSRTS050352017-07-10
00840916109844TALONSPINAL ELEMENTSRTS050402017-07-10
00840916109851TALONSPINAL ELEMENTSRTS050452017-07-10
00840916109868TALONSPINAL ELEMENTSRTS050502017-07-10
00840916109875TALONSPINAL ELEMENTSRTS050552017-07-10
00840916109882TALONSPINAL ELEMENTSRTS060352017-07-10
00840916109899TALONSPINAL ELEMENTSRTS060402017-07-10
00840916109905TALONSPINAL ELEMENTSRTS060452017-07-10
00840916109912TALONSPINAL ELEMENTSRTS060502017-07-10
00840916109929TALONSPINAL ELEMENTSRTS060552017-07-10
00840916109936TALONSPINAL ELEMENTSRTS070352017-07-10
00840916109943TALONSPINAL ELEMENTSRTS070402017-07-10
00840916109950OMNISPINAL ELEMENTSRTS070452017-07-10
00840916109967TALONSPINAL ELEMENTSRTS070502017-07-10
00840916109974TALONSPINAL ELEMENTSRTS070552017-07-10
00840916109981TALONSPINAL ELEMENTSRTS080352017-07-10
00840916109998TALONSPINAL ELEMENTSRTS080402017-07-10
00840916110000TALONSPINAL ELEMENTSRTS080452017-07-10
00840916110017TALONSPINAL ELEMENTSRTS080502017-07-10
00840916110024TALONSPINAL ELEMENTSRTS080552017-07-10
00840916110055TALONSPINAL ELEMENTSST0701102017-07-10
00840916110062TALONSPINAL ELEMENTSST070602017-07-10
00840916110079TALONSPINAL ELEMENTSST070702017-07-10
00840916110086TALONSPINAL ELEMENTSST070802017-07-10
00840916110093TALONSPINAL ELEMENTSST070902017-07-10
00840916110109TALONSPINAL ELEMENTSST0801002017-07-10
00840916110116TALONSPINAL ELEMENTSST0801102017-07-10
00840916110123TALONSPINAL ELEMENTSST080602017-07-10
00840916110130TALONSPINAL ELEMENTSST080702017-07-10