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
699
Last updated
2026-07-17 22:01:43

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08800313235715SQ AXEL Guide CountersinkDENTIS CO. ,LTDDSAGCS502026-07-09
08800313235722SQ AXEL Guide CountersinkDENTIS CO. ,LTDDSAGCS462026-07-09
08800313235739SQ AXEL Guide CountersinkDENTIS CO. ,LTDDSAGCS422026-07-09
08800313235746SQ AXEL Guide CountersinkDENTIS CO. ,LTDDSAGCS382026-07-09
07613327172706ASNISStryker GmbH7053632016-07-25
07613327172737ASNISStryker GmbH7053652016-07-25
07613327172751ASNISStryker GmbH7053642016-07-25
008401944961243P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3120-80002026-06-10
008401944963913P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3124-80002026-06-10
008401944966673P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3127-80002026-06-10
008401944969333P Small-Mini Frag SystemORTHOPEDIATRICS CORP.01-3135-80002026-06-10
10855068008614CountersinkCURVAFIX, INC.CCB-0032022-12-05
00196449017591A.L.P.S. mvX™Tyber Medical, LLC770008200A2026-06-04
00196449017607A.L.P.S. mvX™Tyber Medical, LLC770008240A2026-06-04
00196449017614A.L.P.S. mvX™Tyber Medical, LLC770008270A2026-06-04
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