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
1,796
Last updated
2026-10-04 01:20:19

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10888857401167OZARK Cervical Plate SystemVB Spine LLC8801-900652022-05-31
10888857401181OZARK Cervical Plate SystemVB Spine LLC8801-900672022-05-31
10888857401204OZARK Cervical Plate SystemVB Spine LLC8801-900692022-05-31
10888857401228OZARK Cervical Plate SystemVB Spine LLC8801-900712022-05-31
10888857486973Navigation InstrumentsVB Spine LLC7601-N90009-M2020-10-29
10888857486980Navigation InstrumentsVB Spine LLC7601-N90010-M2020-10-29
10888857515635Navigated Spine InstrumentsVB Spine LLC7601-N90009-K2021-06-16
10888857515642Navigated Spine InstrumentsVB Spine LLC7601-N90010-K2021-06-16
10888857591028YUKON OCT Spinal SystemVB Spine LLC7601-902042025-12-09
10888857596900OZARK Cervical Plate SystemVB Spine LLCPRO-1427-102026-05-01
10888857596924OZARK Cervical Plate SystemVB Spine LLCPRO-1427-142026-05-01
10888857596931OZARK Cervical Plate SystemVB Spine LLCPRO-1427-162026-05-01
10888857596948OZARK Cervical Plate SystemVB Spine LLCPRO-1427-182026-05-01
00885556847329UNI-CP Compression PlateSmith & Nephew, Inc.219535ND2023-10-26
00888867574540Arthrex®ARTHREX, INC.AR-8719T-042026-09-18
00888867574557Arthrex®ARTHREX, INC.AR-8719T-052026-09-18
00885556811269AETOS Shoulder SystemSmith & Nephew, Inc.DRL-0990-8562023-02-09
10888857596917OZARK Cervical Plate SystemVB Spine LLCPRO-1427-122026-05-01
10885862010551NAExactech, Inc.101-05-032022-08-18
07613154633326NAStryker GmbH45-20011S2018-09-24
07613154633432NAStryker GmbH45-30011S2018-09-24
07613327083286AXSOSStryker GmbH705077S2016-09-24
07613327083323AXSOSStryker GmbH705078S2016-09-24
07613327083330AXSOSStryker GmbH705031S2016-09-24
07613327083378AXSOSStryker GmbH705043S2016-09-24
07613327083415AXSOSStryker GmbH705032S2016-09-24
07613327083439AXSOSStryker GmbH705025S2016-09-24
00193982506186N/AGLOBUS MEDICAL, INC.6257.2036S2026-08-14
00193982506193N/AGLOBUS MEDICAL, INC.6257.2037S2026-08-14
07613153170549NAStryker Leibinger GmbH & Co. KG60-167202016-08-24
B56251300102015G10WishBone Plate & Screw SystemWishbone Medical, Inc.51-300-102015G-12022-07-14
B56251300102715G10WishBone Plate & Screw SystemWishbone Medical, Inc.51-300-102715G-12022-07-14
B56251300102815G10WishBone Plate & Screw SystemWishbone Medical, Inc.51-300-102815G-12022-07-14
B56251300103515G10WishBone Plate & Screw SystemWishbone Medical, Inc.51-300-103515G-12022-07-14
00860016074101CARTISTEM® Subchondral Bone Drill Bit - 4mmMedipost, Inc.4mm2026-07-28
03700569674366Newclip InstrumentsNEWCLIP TECHNICSANC1583-ST2026-07-28
03700569674700Newclip InstrumentsNEWCLIP TECHNICSANC416-ST2026-07-28
03700569680237Newclip InstrumentsNEWCLIP TECHNICSANC1886-ST2026-07-28
00889024709188DISTAL GRADUATED DRILL SHORTBiomet Orthopedics, LLC2112-01-4062026-07-24
04546540246332NAStryker Leibinger GmbH & Co. KG60-101042016-08-24
04546540246356NAStryker Leibinger GmbH & Co. KG60-101082016-08-24
04546540246387NAStryker Leibinger GmbH & Co. KG60-101122016-08-24
04546540366467NAStryker Leibinger GmbH & Co. KG60-095042016-08-24
04546540366481NAStryker Leibinger GmbH & Co. KG60-105122016-08-24
04546540366498NAStryker Leibinger GmbH & Co. KG60-135062016-08-24
04546540366504NAStryker Leibinger GmbH & Co. KG60-135122016-08-24
04546540366511NAStryker Leibinger GmbH & Co. KG60-135702016-08-24
04546540390578NAStryker Leibinger GmbH & Co. KG60-105062016-08-24
07613153068518NAStryker Leibinger GmbH & Co. KG60-200122016-08-24
07613153159780NAStryker Leibinger GmbH & Co. KG60-105042016-08-24
07613153170563NAStryker Leibinger GmbH & Co. KG60-107062016-08-24
07613153170570NAStryker Leibinger GmbH & Co. KG60-137122016-08-24
07613153170600NAStryker Leibinger GmbH & Co. KG60-137702016-08-24
07613153170617NAStryker Leibinger GmbH & Co. KG60-137062016-08-24
07613153170624NAStryker Leibinger GmbH & Co. KG60-107122016-08-24
07613154153237NAStryker Leibinger GmbH & Co. KG92-135182016-08-24
07613154183913NAStryker Leibinger GmbH & Co. KG60-135052016-08-24
07613154183920NAStryker Leibinger GmbH & Co. KG60-137052016-08-24
07613154183937NAStryker Leibinger GmbH & Co. KG60-140082016-08-24
07613154183944NAStryker Leibinger GmbH & Co. KG60-147082016-08-24
07613327089936NAStryker Leibinger GmbH & Co. KG60-109082016-08-24
07613327089998NAStryker Leibinger GmbH & Co. KG60-149082016-08-24
18059015378306Orthofix Implantable Bone ScrewsORTHOFIX SRL12026-07-23
18059015378313Orthofix Implantable Bone ScrewsORTHOFIX SRL12026-07-23
B803SYN31005100ORTHOMEDORTHO-MED, INC.OM SYN3105102026-07-22
B803SYN310230ORTHOMEDORTHO-MED, INC.OM SYN310.232026-07-22
04546540246974NAStryker Leibinger GmbH & Co. KG60-154862016-08-24
04546540246981NAStryker Leibinger GmbH & Co. KG60-154962016-08-24
04546540356499NAStryker Leibinger GmbH & Co. KG60-160052016-08-24
04546540356505NAStryker Leibinger GmbH & Co. KG60-160072016-08-24
04546540356512NAStryker Leibinger GmbH & Co. KG60-160352016-08-24
04546540356529NAStryker Leibinger GmbH & Co. KG60-160502016-08-24
04546540356536NAStryker Leibinger GmbH & Co. KG60-190352016-08-24
04546540356543NAStryker Leibinger GmbH & Co. KG60-200502016-08-24
04546540366528NAStryker Leibinger GmbH & Co. KG60-165352016-08-24
04546540366535NAStryker Leibinger GmbH & Co. KG60-168202016-08-24
04546540366542NAStryker Leibinger GmbH & Co. KG60-169082016-08-24
04546540366559NAStryker Leibinger GmbH & Co. KG60-169182016-08-24
04546540366573NAStryker Leibinger GmbH & Co. KG60-195062016-08-24
04546540366580NAStryker Leibinger GmbH & Co. KG60-195352016-08-24