FDA.reportPublic FDA data

Spinal bone screw, 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 stabilization device (e.g., rod, plate) to bone; it is made of a material that is chemically degraded and typically absorbed via natural body processes (e.g., degradable polymers). It is available in various types (e.g., pedicle or transfacet, with a slotted, cross, star, or polygonal drive), and is typically used in spinal discectomy and fusion procedures as a means to maintain the relative position of bone allografts or autografts.
GUDID devices
42
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
008401853653924CIS SARA/VERTU SPINE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAISP-1517-55012026-05-16
008401853821394CIS SARA/VERTU SPINE SYSTEMSOLCO BIOMEDICAL COMPANY INDIA PRIVATE LIMITEDAISP-1517-55012026-05-16
00810131880859 4.5mm Drill Bit - Non-CervicalSurgentec, LLC SR12-63082024-09-12
00810131880866 5.0mm Drill Bit - Non-CervicalSurgentec, LLC SR12-63102024-09-12
00810131880873 5.5mm Drill Bit - Non-CervicalSurgentec, LLC SR12-63092024-09-12
00810131880880 Plastic Drill Guide Non-CervicalSurgentec, LLC SR12-63022024-09-12
00810131881238 Plastic Circular Decortication RaspSurgentec, LLC SR12-63202024-09-12
00810131881399 Impactor 7mm Surgentec, LLC SR12-61012024-09-12
00850040139105 Graft TampSurgentec, LLC SR12-60142024-09-12
00850040139112 Facet Locator - LongSurgentec, LLC SR12-60212024-09-12
00850040139129 Decortication RaspSurgentec, LLC SR12-60202024-09-12
00850040139136 Facet Screw Inserter AO - Cannulated RemovalSurgentec, LLC SR12-60222024-09-12
00850040139143 Removal SleeveSurgentec, LLC SR12-60242024-09-12
00850040139396 Site Prep RaspSurgentec, LLC SR12-62002024-09-12
00850040139419 Site Prep Locator - Teeth SeriesSurgentec, LLC SR12-62112024-09-12
00850040139426 Site Prep Locator - Flat Series Surgentec, LLC SR12-62122024-09-12
00850040139464 Site Prep Removal ToolSurgentec, LLC SR12-62302024-09-12
00850040139594 Site Prep ImpactorSurgentec, LLC SR12-62012024-09-12
00850040139600 Site Prep Barbed GuideSurgentec, LLC SR12-62202024-09-12
00850040139617 Site Prep Barbed Guide +4mm ShimSurgentec, LLC SR12-62212024-09-12
00850040139624 Site Prep Barbed Guide +2mm ShimSurgentec, LLC SR12-62222024-09-12
00858406007594 4.5mm Drill Bit - LongSurgentec, LLC SR12-60112024-09-12
00858406007792 5.0mm Drill Bit - LongSurgentec, LLC SR12-60122024-09-12
00858406007808 5.5mm Drill Bit - LongSurgentec, LLC SR12-60132024-09-12
00858406007884 ION Sterilization TraySurgentec, LLC SR12-70072024-09-12
00858406007891 ION implant caddy smallSurgentec, LLC SR12-70032024-09-12
00858406007907 ION implant caddy largeSurgentec, LLC SR12-70062024-09-12
00810131880033ION AO Coupling Big HandleSurgentec, LLCSR12-50052024-09-11
00810131880392ION AO Coupling Cannulated HandleSurgentec, LLCSR12-50062024-09-11
00810131880538 ION AO Coupling Cannulated Handle - SolcoSurgentec, LLCSR12-50072024-09-11
00810131881221Plastic Graft TampSurgentec, LLCSR12-30032024-09-11
00810131881245 Facet Locator - 7.0mmSurgentec, LLC SR12-60072024-09-11
00850040139990 ION AO Coupling HandleSurgentec, LLCSR12-50042024-09-11
00858406007723 5.5mm Drill BitSurgentec, LLC SR12-60092024-09-11
00858406007747 5.0mm Drill BitSurgentec, LLC SR12-60102024-09-11
00858406007761Medium Axial AO Ratcheting HandleSurgentec, LLCSR12-50002024-09-11
00858406007778 Facet Screw InserterSurgentec, LLC SR12-60012024-09-11
00858406007815 4.5mm Drill Bit - Facet ScrewSurgentec, LLC SR12-60082024-09-11
00858406007822Medium AO Ratcheting T HandleSurgentec, LLCSR12-50022024-09-11
00858406007839 Plastic Drill GuideSurgentec, LLC SR12-60022024-09-11
00858406007860 Facet Screw Drill GuideSurgentec, LLC SR12-60062024-09-11
00858406007945Pin PullerSurgentec, LLCSR12-50032024-09-11