FDA.reportPublic FDA data

Spinal bone set screw

Definition
A small, implantable, non-bioabsorbable disc, threaded on its outside surface, intended to be threaded into the internal proximal end of a spinal bone screw head/rod adaptor, anchor, connector and/or hook (none included) to secure/stabilize a rod and/or tether as part of an internal spinal fixation procedure or a treatment for idiopathic scoliosis. It is made of metal (e.g., surgical steel, titanium alloy).
GUDID devices
103
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810005111249OrthoCircle Spine Pedicle Screw SystemOrthoCircle SpineSSC1.0112020-03-29
03662663180047Polaris 4.75 Deformity SystemHighridge Medical, LLC14-5890012025-11-21
03662663182843Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLC2000-10052025-11-21
03662663182850Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLC2000-1005E2025-11-21
03662663182867Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLC2000-10082025-11-21
03662663182874Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLC2000-1008E2025-11-21
04047844032367DIPLOMATSIGNUS Medizintechnik GmbHSet screw T302019-10-24
04047844101315COSYSIGNUS Medizintechnik GmbHOcciput set screw T152023-03-21
04047844102503COSYSIGNUS Medizintechnik GmbHSet screw parallel/inline connector T152023-03-21
04047844102718COSYSIGNUS Medizintechnik GmbHSet screw tulips cross connector T152023-03-21
04047844102725COSYSIGNUS Medizintechnik GmbHRetaining nut tulips cross connector2023-03-21
04047844102732COSYSIGNUS Medizintechnik GmbHSet screw tulips cross connector, reduction T152023-03-21
07290110207373CarboClear X Pedicle Screw SystemCARBOFIX ORTHOPEDICS LTDLocking Element - Set Screw2021-06-29
07290117353387CarboClear Posterior Cervical Screw SystemCARBOFIX ORTHOPEDICS LTDLocking Element2024-06-05
07290117353547CarboClear Hybrid Pedicle Screw SystemCARBOFIX ORTHOPEDICS LTDSet Screw2024-07-14
07290117356869CarboClear Posterior Cervical Screw SystemCARBOFIX ORTHOPEDICS LTDSet Screw2026-03-25
07630542758621M.U.S.T. Pedicle Screw SystemMedacta International SA03.47.1502026-05-04
07630542758638M.U.S.T. Pedicle Screw SystemMedacta International SA03.47.1512026-05-04
07630542758645M.U.S.T. Pedicle Screw SystemMedacta International SA03.47.1522026-05-04
07630542758652M.U.S.T. Pedicle Screw SystemMedacta International SA03.47.1532026-05-04
07640221373007PERLA ® TLSpineArt SATLF-SC 10 00-S2026-05-06
07640221373014PERLA ® TLSpineArt SATLF-SC 12 00-S2026-05-06
07640387660140GoPLF! Posterior Lateral Fusion DeviceGetSet Surgical SA31000102023-12-12
08800044768803The JASPER Spinal Fixation System60GBS Commonwealth Co.,Ltd.L131-00012019-11-20
088063735240594CIS® Spinal System and 4CIS® Low Back SystemALPHA AI CO.,LTD.4202-00032026-04-15
088063735241654CIS® Spinal System and 4CIS® Low Back SystemALPHA AI CO.,LTD.4212-00012026-04-15
088063735241724CIS® Spinal System and 4CIS® Low Back SystemALPHA AI CO.,LTD.4212-00022026-04-15
088063735297404CIS® Spinal System and 4CIS® Low Back SystemALPHA AI CO.,LTD.62-400012026-04-15
088063735297574CIS® Spinal System and 4CIS® Low Back SystemALPHA AI CO.,LTD.62-400022026-04-15
10705034709864NASynthes GmbHSD496.0012015-09-14
10705034709871NASynthes GmbHSD496.0022015-09-14
10705034736662USSSynthes GmbH04.607.4122015-09-14
10705034739359NASynthes GmbH04.614.5212015-09-14
10705034743233USSSynthes GmbH04.621.1902015-09-14
10705034744964MatrixSynthes GmbH04.632.0002015-09-14
10705034763194MatrixSynthes GmbH09.632.0992015-09-14
10705034764443NASynthes GmbH298.0032015-09-14
10705034764450NASynthes GmbH298.0112015-09-14
10705034764481NASYNTHES (U.S.A.) LP298.0202015-09-14
10705034764498NASYNTHES (U.S.A.) LP298.0212015-09-14
10705034764504NASYNTHES (U.S.A.) LP298.0222015-09-14
10705034767543NASYNTHES (U.S.A.) LP299.2922015-09-14
10705034767550NASYNTHES (U.S.A.) LP299.2932015-09-14
10705034767567NASYNTHES (U.S.A.) LP299.2942015-09-14
10705034787589NASYNTHES (U.S.A.) LP497.1382015-09-14
10705034788579NASynthes GmbH498.0032015-09-14
10705034788586NASynthes GmbH498.0102015-09-14
10705034788593NASynthes GmbH498.0112015-09-14
10705034788616NASynthes GmbH498.0202015-09-14
10705034788623NASynthes GmbH498.0212015-09-14
10705034788630NASynthes GmbH498.0222015-09-14
10705034791081Click'XSynthes GmbH498.5702015-09-14
10705034791746NASynthes GmbH498.8112015-09-14
20705034595549TRIALTISMedos International Sàrl5560-01-00X4S2024-08-16
20705034595884TRIALTISMedos International Sàrl5560-01-00X8S2024-08-16
20705034596898TRIALTISMedos International Sàrl5560-01-00X2S2024-08-16
20705034596904TRIALTISMedos International Sàrl5560-01-00X6S2024-08-16
B064XM21700131SETx Lateral Mass - Individual Set ScrewXENCO MEDICAL LLCXM-217-00132025-11-06
B064XMPH21500131Single Set Screw for Pedicle ScrewXENCO MEDICAL LLCXM-PH-215-00132025-11-09
B064XMPH21700131SINGLE SET SCREW FOR LATERAL MASS SCREWXENCO MEDICAL LLCXM-PH-217-00132025-11-06
B064XMPH23555501Ø5.5mm X 50mm CANNULATED REDUCTION SCREW WITH SET SCREWXENCO MEDICAL LLCXM-PH-235-55502025-11-08
B515LC020Locking Cap (Set Screw)SPINAL RESOURCES, INC.LC-022026-05-15
M824A3ST151ASTRA-OCT Spine SystemSPINECRAFT, LLCA3S-T152018-10-03
M824A3ST15C1ASTRA-OCT Spine SystemSPINECRAFT, LLCA3S-T15C2018-10-03
M824A3ST15F1ASTRA-OCT Spine SystemSPINECRAFT, LLCA3S-T15F2018-10-03
M824A3SXN1ASTRA-OCT Spine SystemSPINECRAFT, LLCA3S-XN2018-10-03
M824A3SXT151ASTRA-OCT Spine SystemSPINECRAFT, LLCA3S-XT152018-10-03
00840283401404VyLink™VY SPINE LLC04-SS-4585-TI-N2026-03-11
00850062071001A8 INTEGR8® Porous Pedicle Screw SystemALLUMIN8, INC.A8-00-CAP2026-02-27
00850080774335A8 INTEGR8® Porous Pedicle Screw SystemALLUMIN8, INC.A8-27-CAP2026-02-27
10840642177008Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.11-87442026-01-15
10840642177794Proficient® Posterior Cervical Spine SystemSpine Wave, Inc.11-87492026-01-15
03662663146524Gallery Laminoplasty Fixation SystemHighridge Medical, LLC14-5231042026-01-13
10840642173086Annex® 2 Adjacent Level SystemSpine Wave, Inc.11-58132026-01-09
10840642173093Annex® 2 Adjacent Level SystemSpine Wave, Inc.11-58162026-01-09
10840642177121Annex® 2 Adjacent Level SystemSpine Wave, Inc.11-58152026-01-09
088000333579334CIS SOLAR SPINE SYSTEMALPHA AI CO.,LTD.4222-00012015-09-24
088000333580534CIS APOLLON SPINE SYSTEMALPHA AI CO.,LTD.4232-08552015-09-24
088000333580604CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.4242-00032016-08-12
088000333820274CIS VANE SPINE SYSTEMALPHA AI CO.,LTD.4242-00042015-09-24