FDA.reportPublic FDA data

Fluted surgical drill bit, single-use

Definition
"A shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a ""twist drill"", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is mounted into a surgical power tool or a surgical hand drill/brace. This is a single-use device."
GUDID devices
352
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00190376475707InvictusALPHATEC SPINE, INC.17833-028-N2023-01-05
00190376475721InvictusALPHATEC SPINE, INC.17833-035-N2023-01-05
00190376475745InvictusALPHATEC SPINE, INC.17833-041-N2023-01-05
00190376475769InvictusALPHATEC SPINE, INC.17833-048-N2023-01-05
00763000311766KYPHON® Precision DrillMEDTRONIC SOFAMOR DANEK, INC.T34F2020-11-06
00763000665159n/aMEDTRONIC SOFAMOR DANEK, INC.30340012026-04-27
00763000885649n/aMEDTRONIC SOFAMOR DANEK, INC.876-4432026-05-01
00763000885656n/aMEDTRONIC SOFAMOR DANEK, INC.876-4552026-05-15
00810111227162DrillTreace Medical Concepts, Inc.02-004572026-03-30
00810111227179Drill Treace Medical Concepts, Inc.02-004562026-03-26
00810111227186DrillTreace Medical Concepts, Inc.02-004552026-03-27
00810111227193DrillTreace Medical Concepts, Inc.02-004542026-03-31
00810111227209DrillTreace Medical Concepts, Inc.02-004532026-03-30
00840097532356Veritas rTSA InstrumentationRestor3d, Inc.6500-20472026-05-14
00841731135292Redemption VILEX LLCRD-DRILL-432026-01-12
00841731152107DYNEX VILEX LLCDXT-TTT-052026-05-11
00841731152114DYNEX VILEX LLCDXT-TTT-062026-05-11
00841731152169DYNEX VILEX LLCDXT-TTT-112026-05-11
00841731152176DYNEX VILEX LLCDXT-TTT-122026-05-11
00841823101150Disposable Drill KitAd-Tech Medical Instrument CorporationDDK2-2.4-30N2017-12-27
00841823101167Disposable Drill KitAd-Tech Medical Instrument CorporationDDK2-2.4-30X2017-12-27
00841823101174Disposable Drill KitAd-Tech Medical Instrument CorporationDDK2-2.8-30X2017-12-27
00841823101181Disposable Drill KitAd-Tech Medical Instrument CorporationDDK2-3.2-30X2017-12-27
00846832087037Tornier PerformTORNIER, INC.IFX8122022-12-21
00850052601218Orca™ Xtreme Implantation Kit DUNAMIS MEDICAL, LLCAB-69502024-02-13
00885554000078NASmith & Nephew, Inc.722028162015-09-28
00885554000085NASmith & Nephew, Inc.722028172015-09-28
00885554000115NASmith & Nephew, Inc.722028122015-09-28
00885554000122NASmith & Nephew, Inc.722028132015-09-28
00885554015157NASmith & Nephew, Inc.722019132015-09-28
00887868568367JUGGERKNOT®Biomet Orthopedics, LLC9120362026-02-23
00887868568374JuggerKnot®Biomet Orthopedics, LLC9120712022-12-13
00888118132581LEVEL ONE SMALL BONE, STERILEKLS-Martin L.P.26-850-10-712026-04-23
00888118132628LEVEL ONE SMALL BONE, STERILEKLS-Martin L.P.26-850-20-712026-04-23
00888118132697LEVEL ONE SMALL BONE, STERILEKLS-Martin L.P.26-875-10-712026-04-23
00888118132734LEVEL ONE SMALL BONE, STERILEKLS-Martin L.P.26-875-20-712026-04-23
00888118132758LEVEL ONE SMALL BONE, STERILEKLS-Martin L.P.26-875-29-712026-04-23
00888118132765LEVEL ONE SMALL BONE, STERILEKLS-Martin L.P.26-875-30-712026-04-23
00888118132772LEVEL ONE SMALL BONE, STERILEKLS-Martin L.P.26-875-31-712026-04-23
00888118133182LEVEL ONE EXTREMITYKLS-Martin L.P.26-950-20-072026-04-23
00888118133199LEVEL ONE EXTREMITY, STERILEKLS-Martin L.P.26-950-20-712026-04-23
00888118133205LEVEL ONE EXTREMITYKLS-Martin L.P.26-950-25-072026-04-23
00888118133212LEVEL ONE EXTREMITY, STERILEKLS-Martin L.P.26-950-25-712026-04-23
00888118133229LEVEL ONE EXTREMITYKLS-Martin L.P.26-950-30-072026-04-23
00888118133236LEVEL ONE EXTREMITY, STERILEKLS-Martin L.P.26-950-30-712026-04-23
00888118133243LEVEL ONE EXTREMITYKLS-Martin L.P.26-950-31-072026-04-23
00888118133250LEVEL ONE EXTREMITY, STERILEKLS-Martin L.P.26-950-31-712026-04-23
00888118147318LEVEL ONEKLS-Martin L.P.25-456-03-912025-10-23
00888118147325LEVEL ONE, STERILEKLS-Martin L.P.25-456-03-712025-10-23
00888118147332LEVEL ONEKLS-Martin L.P.50-812-03-912025-10-23
00888118147349LEVEL ONE, STERILEKLS-Martin L.P.50-812-03-712025-10-23
00888118147356LEVEL ONEKLS-Martin L.P.25-456-04-912025-10-23
00888118147363LEVEL ONE, STERILEKLS-Martin L.P.25-456-04-712025-10-23
00888118147370LEVEL ONEKLS-Martin L.P.50-812-04-912025-10-23
00888118147387LEVEL ONE, STERILEKLS-Martin L.P.50-812-04-712025-10-23
00888118147394LEVEL ONEKLS-Martin L.P.25-456-05-912025-10-23
00888118147400LEVEL ONE, STERILEKLS-Martin L.P.25-456-05-712025-10-23
00888118147417LEVEL ONEKLS-Martin L.P.50-812-05-912025-10-23
00888118147424LEVEL ONE, STERILEKLS-Martin L.P.50-812-05-712025-10-23
00888118147431LEVEL ONEKLS-Martin L.P.25-456-07-912025-10-23
00888118147448LEVEL ONE, STERILEKLS-Martin L.P.25-456-07-712025-10-23
00888118147455LEVEL ONEKLS-Martin L.P.50-812-07-912025-10-23
00888118147462LEVEL ONE, STERILEKLS-Martin L.P.50-812-07-712025-10-23
00888118147479LEVEL ONEKLS-Martin L.P.25-456-13-912025-10-23
00888118147486LEVEL ONE, STERILEKLS-Martin L.P.25-456-13-712025-10-23
00888118147493LEVEL ONEKLS-Martin L.P.50-812-13-912025-10-23
00888118147509LEVEL ONE, STERILEKLS-Martin L.P.50-812-13-712025-10-23
00888867010024Arthrex®ARTHREX, INC.AR-1321D2018-08-03
00888867039803Arthrex®ARTHREX, INC.AR-65232018-08-03
00888867239463Arthrex®ARTHREX, INC.AR-3600NDSR-12018-08-03
00888867269064Arthrex®ARTHREX, INC.AR-1938DSR2018-08-03
00888867269071Arthrex®ARTHREX, INC.AR-2923DTSR2018-08-03
00888867276550Arthrex®ARTHREX, INC.AR-1938DSSK2018-08-03
00888867291805Arthrex®ARTHREX, INC.AR-2922DSR-242018-12-10
00888867296398Arthrex®ARTHREX, INC.AR-2922DTSR-242018-12-10
00888867304833Arthrex®ARTHREX, INC.AR-8973-252022-12-21
00888867320666Arthrex®ARTHREX, INC.AR-8980-02S2020-11-18
00888867385528Arthrex®ARTHREX, INC.AR-18800-162023-01-28
00888867424746Arthrex®ARTHREX, INC.AR-18800-492023-01-28
00889024707054CALIBRATED DRILL BITBiomet Orthopedics, LLC2142-27-0702026-04-27