FDA.reportPublic FDA data

Spinal bone set screw

Definition
A small, threaded, implantable, non-bioabsorbable disc intended to be threaded into the 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
21
Last updated
2025-04-11 13:23:30

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
B1830112000010Canaveral®FLOSPINE LLCCanaveral®2016-06-30
03663136015088P.L.U.S.®SPINEVISIONU1-L100T2015-10-21
03663136005232UNI-THREAD®SPINEVISIONL2-L201T2015-10-15
04718251502254Facilis™ Spinal SystemBAUI BIOTECH CO. LTD.156-1216*2025-01-09
04719883860842NOVA Minimally Invasive SystemBAUI BIOTECH CO. LTD.156-12162025-01-09
03663136015071P.L.U.S.®SPINEVISIONU1-L1002015-10-21
03663136019765UNI-THREAD®SPINEVISIONL2-L200T2015-10-15
03663136006901LUMIS™SPINEVISIONMS1-L100T2015-10-15
03700780609000Erisma™-LPCLARIANCE186200092014-09-19
03663136015231 P.L.U.S.®SPINEVISIONU1-L4022019-02-12
03663136015248 P.L.U.S.®SPINEVISIONU1-L402T2018-11-10
00190376588759InvictusALPHATEC SPINE, INC.111002024-12-03
00190376601618InvictusALPHATEC SPINE, INC.111012024-12-03
08800089439959Xpine Spinal Fixation SystemJeil Medical CorporationL69-P60S-95052024-11-13
09348215030377Freedom Pedicle Screw SystemSIGNATURE ORTHOPAEDICS PTY LTD131-13-00112019-01-17
03700780616251Erisma®-LPCLARIANCE136200092018-06-06
00843210167992SochiAltus Spine, LLCA16-23-00002024-10-03
00840314141798Nex-D2NEXT ORTHOSURGICAL, INC.CBCAJ-100002024-09-16
00840314141804Nex-D2NEXT ORTHOSURGICAL, INC.CBCBJ-100002024-09-16
M824SSM6T20H1APEX Spine SystemSPINECRAFT, LLCSS-M6-T20H2024-09-13
M824SS6MPH95T30XL1APEX Spine SystemSPINECRAFT, LLCSS6-MPH95-T30XL2014-09-24