FDA.reportPublic FDA data

Spinal bone screw head/rod adaptor

Definition
A small, implantable, non-bioabsorbable device intended to be attached to the top end of a spinal screw (not included) typically to secure/stabilize a rod and/or connector as part of an internal spinal fixation procedure. Also known as a reduction head or tulip, it is typically U-shaped with threads to receive a set screw and/or has a hole to allow the rod and/or connector to pass through; it may also facilitate a degree of motion. It is available in various lengths and is made of metal (e.g., surgical steel, titanium alloy) and/or synthetic polymer materials.
GUDID devices
37
Last updated
2026-07-17 21:59:34

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00841732149847TAURUS Pedicle Screw SystemCTL Medical Corporation51-1000-0012023-09-15
00841732149854TAURUS Pedicle Screw SystemCTL Medical Corporation51-1000-0022023-09-15
06009699900817Titamed Spinal SystemTITAMED (PTY) LTDLG2026-05-28
06009699901791Titamed Spinal SystemTITAMED (PTY) LTDLGT2026-05-28
06009699901838Titamed Spinal SystemTITAMED (PTY) LTDMG2026-05-28
00197157026899Zavation Deformity Polyaxial HeadZavation LLC1010-20012024-09-05
00197157026929Zavation Deformity Polyaxial Head – Biased AngleZavation LLC1010-20052024-09-05
00197157069605ZAVATION MODULAR MIS HEAD ASSEMBLYZavation LLC982-20102025-09-16
00197157069612ZAVATION MODULAR MIS HEAD ASSEMBLYZavation LLC982-20152025-09-16
00197157069629ZAVATION MODULAR MIS HEAD ASSEMBLYZavation LLC982-20202025-09-16
00197157069636ZAVATION MODULAR MIS HEAD ASSEMBLYZavation LLC982-20252025-09-16
00197157069643ZAVATION MODULAR MIS HEAD ASSEMBLYZavation LLC982-20302025-09-16
07290109335834CarboClear Pedicle Screw SystemCARBOFIX ORTHOPEDICS LTDLocking Element2018-07-24
07290109336565CarboClear Pedicle Screw SystemCARBOFIX ORTHOPEDICS LTDLocking Element R452018-07-24
07290110201951CarboClear Pedicle Screw SystemCARBOFIX ORTHOPEDICS LTDTrans-Connector Locking Element + Ring2018-10-07
10705034736655USSSynthes GmbH04.607.4022015-09-14
10705034744971MatrixSynthes GmbH04.632.0012015-09-14
10705034747507MatrixSynthes GmbH04.634.0022015-09-14
10705034787572NASYNTHES (U.S.A.) LP497.1372015-09-14
10705034791098Click'XSYNTHES (U.S.A.) LP498.5712015-09-14
10889981332952VirataSeaspine Orthopedics CorporationTL1-400000002025-09-26
00840493415437RIVA Posterior Fixation SystemXENIX MEDICAL LLCFG1-20-0000502025-09-15
00840493415444RIVA Posterior Fixation SystemXENIX MEDICAL LLCFG1-20-0000602025-09-15
00840493415451RIVA Posterior Fixation SystemXENIX MEDICAL LLCFG1-20-0000612025-09-15
00840493413631RIVA Posterior Fixation SystemXENIX MEDICAL LLCFG1-20-0000102025-08-15
00840493413648RIVA Posterior Fixation SystemXENIX MEDICAL LLCFG1-20-0000112025-08-15
04047844067055DIPLOMATSIGNUS Medizintechnik GmbHCross connector tulips, incl. 2x set screws2025-05-30
04047844099346DIPLOMATSIGNUS Medizintechnik GmbHCross connector tulip2025-05-30
04047844127254DIPLOMATSIGNUS Medizintechnik GmbHParallel tulip, lateral, incl. set screws2025-05-30
04047844127261DIPLOMATSIGNUS Medizintechnik GmbHParallel tulip double, angled, incl. set screws2025-05-30
04047844127278DIPLOMATSIGNUS Medizintechnik GmbHParallel tulip double, straight, incl. set screws2025-05-30
04047844127469DIPLOMATSIGNUS Medizintechnik GmbHParallel tulip, lateral2025-05-30
04047844127476DIPLOMATSIGNUS Medizintechnik GmbHParallel tulip double, angled2025-05-30
04047844127483DIPLOMATSIGNUS Medizintechnik GmbHParallel tulip double, straight2025-05-30
00190837171537ARx MISLife Spine, Inc.175-0452025-02-27
10840642175646Salvo® Spine SystemSpine Wave, Inc.11-71002024-10-25
00190837200558ARxLife Spine, Inc.175-0402024-10-02