FDA.reportPublic FDA data

Surgical countersink, reusable

Definition
A rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a reusable device.
GUDID devices
685
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00810190980767Eleganz Fusion Screw SystemDev4DI-20312025-10-01
00810190981474Eleganz IM Threaded NailDev4MI-25302026-04-23
00810190981481Eleganz IM Threaded NailDev4MI-35302026-04-23
00810190981498Eleganz IM Threaded NailDev4MI-45302026-04-23
00810211043945Ultra Compression Screw SystemPace Surgical, Inc.PS2-11000462026-04-27
00810211043952Ultra Compression Screw SystemPace Surgical, Inc.PS2-11000552026-04-27
00810211043969Ultra Compression Screw SystemPace Surgical, Inc.PS2-12000342026-04-27
00810211043976Ultra Compression Screw SystemPace Surgical, Inc.PS2-12000382026-04-27
00810211043983Ultra Compression Screw SystemPace Surgical, Inc.PS2-13000652026-04-27
00810211043990Ultra Compression Screw SystemPace Surgical, Inc.PS2-13000752026-04-27
00810211044003Ultra Compression Screw SystemPace Surgical, Inc.PS2-14000502026-04-27
00810211044010Ultra Compression Screw SystemPace Surgical, Inc.PS2-14000612026-04-27
00840118126250Active CompressionFLOWER ORTHOPEDICS CORPORATIONOCC0552025-11-21
00840118126267Active CompressionFLOWER ORTHOPEDICS CORPORATIONOCC0702025-11-21
00841731135308Redemption VILEX LLCRD-C652026-01-12
00841731146854TITANEX VILEX LLCUZ-CS202026-05-15
00841731146878TITANEX VILEX LLCUZ-CS302026-05-15
00841731146892TITANEX VILEX LLCUZ-CS402026-05-15
00841731146915TITANEX VILEX LLCUZ-CS502026-05-15
00841731146939TITANEX VILEX LLCUZ-CS702026-05-15
00887868049453SOLID COUNTERSINKBiomet Orthopedics, LLC8242-20-0002020-05-23
00887868049460SOLID COUNTERSINKBiomet Orthopedics, LLC8242-20-1002020-05-23
00887868067730COUNTERSINKBiomet Orthopedics, LLC9399992522020-05-23
00889795141330Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.P32-960-00012025-11-19
00889797106061Made-To-OrderWRIGHT MEDICAL TECHNOLOGY, INC.SMS003442022-12-08
00889797106085Made-To-OrderWRIGHT MEDICAL TECHNOLOGY, INC.SMS003452022-12-08
00889797106108Made-To-OrderWRIGHT MEDICAL TECHNOLOGY, INC.SMS003462022-12-08
00889797106610Made-To-OrderWRIGHT MEDICAL TECHNOLOGY, INC.SMS003792022-12-08
00889797106719Made-To-OrderWRIGHT MEDICAL TECHNOLOGY, INC.SMS003872022-12-08
03700569610579Newclip InstrumentsNEWCLIP TECHNICSANC8452026-05-12
03700569620325Newclip InstrumentsNEWCLIP TECHNICSANC2022026-05-07
03700569621582Newclip InstrumentsNEWCLIP TECHNICSANC4172026-05-11
03700569621599Newclip InstrumentsNEWCLIP TECHNICSANC4182026-05-11
03700569621605Newclip InstrumentsNEWCLIP TECHNICSANC4192026-05-11
03700569621919Newclip InstrumentsNEWCLIP TECHNICSANC4632026-05-11
03700569622398Newclip InstrumentsNEWCLIP TECHNICSANC5732026-05-11
03700569625191Newclip InstrumentsNEWCLIP TECHNICSANC6642026-05-12
03700569679170Newclip InstrumentsNEWCLIP TECHNICSANC16072026-05-05
03700569679187Newclip InstrumentsNEWCLIP TECHNICSANC16082026-05-05
03700569679743Newclip InstrumentsNEWCLIP TECHNICSANC18072026-05-07
04042409037627NAaap Implantate AGIS 1302-162018-02-28
04042409041266NAaap Implantate AGIU 7611-002018-02-28
04042409041280NAaap Implantate AGIU 7620-002018-02-28
04042409041303NAaap Implantate AGIU 7632-002018-02-28
04042409174155NAaap Implantate AGIS 1305-162018-02-28
04042409174414NAaap Implantate AGIS 2305-322018-02-28
04042409174773NAaap Implantate AGIW2305322018-02-28
04042409193163NAaap Implantate AGIS 2310-222018-02-28
04042409193170NAaap Implantate AGIS 2310-322018-02-28
04042409194504NAaap Implantate AGIS 1305-082018-02-28
05060440334368Neoss Implant SystemNeoss AB412102019-11-25
05060440334375Neoss Implant SystemNeoss AB412112019-11-25
05060440334382Neoss Implant SystemNeoss AB412122019-11-25
05060440334399Neoss Implant SystemNeoss AB412132019-11-25
06438408000324Inion® Universal instrumentsInion Oy12020-05-08
06438408002212Inion® Universal instrumentsInion Oy12020-05-08
06438408002946Inion® Universal instrumentsInion Oy12020-05-08
06438408002953Inion® Universal instrumentsInion Oy12020-05-08
06438408004018Inion FreedomScrew instrumentsInion Oy12020-05-08
06438408004025Inion FreedomScrew instrumentsInion Oy12020-05-08
07290108819502Countersink DrillNORIS MEDICAL LTDNMCD10342025-11-10
07290108819519Countersink DrillNORIS MEDICAL LTDNMCD10562025-11-10
08057717552911BRM TOOL PRO SCREWS INSTRUMENTBRM EXTREMITIES SRLBasic Countersink Ø 5,62025-10-15
08057717552928BRM TOOL PRO SCREWS INSTRUMENTBRM EXTREMITIES SRLBasic countersink Ø 7.02025-10-15
08437019739430WasherCap™ Countersink 11 mmABANZA TECNOMED SL.212026-03-30
08800089436132Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationSO-111-1352023-01-17
08806169136992s-Clean Tapered CountersinkDENTIS CO. ,LTDDSTCS372021-05-28
08806169137005s-Clean Tapered CountersinkDENTIS CO. ,LTDDSTCS412021-05-28
08806169137012s-Clean Tapered CountersinkDENTIS CO. ,LTDDSTCS432021-05-28
08806169137029s-Clean Tapered CountersinkDENTIS CO. ,LTDDSTCS482021-05-28
08806390857437VERUM System Surgical InstrumentJeil Medical CorporationCC00502018-09-07
08806390865265Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationSO-111-0722018-09-07
08806390870702VERUM System Surgical InstrumentJeil Medical CorporationCC03202018-12-17
08806390871419VERUM System Surgical InstrumentJeil Medical CorporationVC00402018-12-17
08806390873413VERUM System Surgical InstrumentJeil Medical CorporationVF01202018-12-17
10806378051982ACUMEDAcumed LLC80-18722015-10-24
10806378052958ACUMEDAcumed LLC80-18072015-10-24
10806378071256ACUMEDAcumed LLCLAG-10002015-10-24
10806378074547ACUMEDAcumed LLCPL-20802015-10-24
10806378091087ACUMEDAcumed LLC80-20292015-10-24