FDA.reportPublic FDA data

Surgical countersink, single-use

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 single-use device intended to be sterilized prior to use.
GUDID devices
227
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00887868027031COUNTERSINKBiomet Orthopedics, LLC2312-20-2062020-05-23
00887868027048COUNTERSINKBiomet Orthopedics, LLC2312-20-2072020-05-23
03700569605070Newclip InstrumentsNEWCLIP TECHNICSANC8432026-05-12
03700569605087Newclip InstrumentsNEWCLIP TECHNICSANC8422026-05-12
03700569617707Newclip InstrumentsNEWCLIP TECHNICSANC2032026-05-07
03700569617714Newclip InstrumentsNEWCLIP TECHNICSANC4762026-05-11
03700569617738Newclip InstrumentsNEWCLIP TECHNICSANC5382026-05-11
03700569623272Newclip InstrumentsNEWCLIP TECHNICSANC6612026-05-12
05055662932928ORTHO SOLUTIONS STERILE DRILL BITSORTHO SOLUTIONS HOLDINGS LIMITEDOS3190502016-02-19
05055662962444ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESISORTHO SOLUTIONS HOLDINGS LIMITEDOS3051072019-07-26
05055662962451ORTHO SOLUTIONS STERILE DRILL BITSORTHO SOLUTIONS HOLDINGS LIMITEDOS3090082019-07-26
05055662962475ORTHO SOLUTIONS STERILE DRILL BITSORTHO SOLUTIONS HOLDINGS LIMITEDOS3190502019-07-26
05055662962499ORTHO SOLUTIONS EXTREMITY FIXATION IMPLANTS FOR OSTEOSYSNTHESISORTHO SOLUTIONS HOLDINGS LIMITEDOS3200512019-07-26
05055662962505ORTHO SOLUTIONS STERILE DRILL BITSORTHO SOLUTIONS HOLDINGS LIMITEDOS3211102019-07-26
05055662962512ORTHO SOLUTIONS STERILE DRILL BITSORTHO SOLUTIONS HOLDINGS LIMITEDOS3280172019-07-26
05055662962543ORTHO SOLUTIONS STERILE DRILL BITSORTHO SOLUTIONS HOLDINGS LIMITEDOS3230162019-07-26
10887587035505NASynthes GmbH310.802016-06-30
10887587035529NASynthes GmbH310.812016-06-30
10887587035550NASynthes GmbH310.8832016-06-30
B471230000240GEO Bone Screw SystemGRAMERCY EXTREMITY ORTHOPEDICS LLC230000242019-07-25
B471230000360GEO Bone Screw SystemGRAMERCY EXTREMITY ORTHOPEDICS LLC230000362019-07-25
B471230000510GEO Bone Screw SystemGRAMERCY EXTREMITY ORTHOPEDICS LLC230000512019-07-25
B471230000610GEO Bone Screw SystemGRAMERCY EXTREMITY ORTHOPEDICS LLC230000612019-07-25
B471231000810GEO Bone Screw SystemGRAMERCY EXTREMITY ORTHOPEDICS LLC231000812019-07-25
B471231000860GEO Bone Screw SystemGRAMERCY EXTREMITY ORTHOPEDICS LLC231000862019-07-25
00888867529779Arthrex®ARTHREX, INC.AR-8974-212026-03-16
05055662971576ORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS HOLDINGS LIMITEDOS353007-NS2026-03-04
00819917026832Cannulated Screw System +Tyber Medical, LLC03.333.213S2020-05-21
M695HTR040045470Orion Headless Screw System InstrumentsTyber Medical, LLCHTR-04-0045472019-12-19
00840124520042PolyLock MidfootFUSION ORTHOPEDICS, LLCTN-MF-21142025-05-16
00840124520059PolyLock MidfootFUSION ORTHOPEDICS, LLCTN-MF-21162025-05-16
00840124520066PolyLock MidfootFUSION ORTHOPEDICS, LLCTN-MF-21182025-05-16
00840124520073PolyLock MidfootFUSION ORTHOPEDICS, LLCTN-MF-21202025-05-16
00840124520080PolyLock MidfootFUSION ORTHOPEDICS, LLCTN-MF-21222025-05-16
00840124520097PolyLock MidfootFUSION ORTHOPEDICS, LLCTN-MF-20142025-05-16
00840124520103PolyLock MidfootFUSION ORTHOPEDICS, LLCTN-MF-20162025-05-16
00840124520110PolyLock MidfootFUSION ORTHOPEDICS, LLCTN-MF-20182025-05-16
00840124520127PolyLock MidfootFUSION ORTHOPEDICS, LLCTN-MF-20202025-05-16
00840124520134PolyLock MidfootFUSION ORTHOPEDICS, LLCTN-MF-20222025-05-16
08800037585325Dyna Locking Cannulated ScrewCG MedTech Co.,Ltd.TC40072024-01-08
08800037585363Dyna Locking Cannulated ScrewCG MedTech Co.,Ltd.TC50072024-01-08
08800037585394Dyna Locking Cannulated ScrewCG MedTech Co.,Ltd.TC65072024-01-08
00840124514379FuzeFix LargeFUSION ORTHOPEDICS, LLCCD-FT-20702024-12-04
00840124514386FuzeFix LargeFUSION ORTHOPEDICS, LLCCD-FT-20552024-12-04
03700569636289Newclip InstrumentsNEWCLIP TECHNICSKIT-MI162024-11-14
03700569636296Newclip InstrumentsNEWCLIP TECHNICSKIT-MI192024-11-14
03700569636302Newclip InstrumentsNEWCLIP TECHNICSKIT-MI222024-11-14
03700569617660Newclip InstrumentsNEWCLIP TECHNICSANC1972024-11-08
03700569617677Newclip InstrumentsNEWCLIP TECHNICSANC1982024-11-08
03700569617691Newclip InstrumentsNEWCLIP TECHNICSANC1992024-11-08
03700569617721Newclip InstrumentsNEWCLIP TECHNICSANC5372024-11-08
03700569617745Newclip InstrumentsNEWCLIP TECHNICSANC5992024-11-08
00889795137098Phantom® Fibula Nail SystemParagon 28, Inc.P36-911-27352024-09-24
M695HTR040099380Orion Headed Screw System InstrumentsTyber Medical, LLCHTR-04-0099382019-12-19
05055662969818COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDOS380023-NS2024-04-01
00889795132802Precision MIS Bunion SystemParagon 28, Inc.P27-940-00302024-01-24
00889795132819Precision MIS Bunion SystemParagon 28, Inc.P27-940-00352024-01-24
00889795132826Precision MIS Bunion SystemParagon 28, Inc.P27-940-00402024-01-24
00841506117683Threaded Hand NailSKELETAL DYNAMICS L.L.C.Countersink, 3.8mm, Cannulated2023-12-22
00841506129433Threaded Hand NailSKELETAL DYNAMICS L.L.C.Countersink, 3.3mm, Cannulated2023-12-22
00810040682025Cannulated Screw System +Tyber Medical, LLC03.333.2152020-05-21
00819917026702Cannulated Screw System +Tyber Medical, LLC03.333.2102020-05-21
00819917026719Cannulated Screw System +Tyber Medical, LLC03.333.2112020-05-21
00819917026726Cannulated Screw System +Tyber Medical, LLC03.333.2122020-05-21
00819917026733Cannulated Screw System +Tyber Medical, LLC03.333.2132020-05-21
00819917026740Cannulated Screw System +Tyber Medical, LLC03.333.2142020-05-21
00841731130976ALPHALOK Plating SystemVILEX LLCTCS20-252023-08-07
00841731129604ALPHALOK Plating SystemVILEX LLCTCS27-352023-07-21
08800015950404Dyna Locking Cannulated ScrewCG MedTech Co.,Ltd.TC40072017-10-27
08800015950473Dyna Locking Cannulated ScrewCG MedTech Co.,Ltd.TC50072017-10-27
08800015950541Dyna Locking Cannulated ScrewCG MedTech Co.,Ltd.TC65072017-10-27
08800015994675Polarfix™ Facet Screw SystemCG MedTech Co.,Ltd.FSA45252018-05-17
08800015994682Polarfix™ Facet Screw SystemCG MedTech Co.,Ltd.FSA45302018-05-17
08800015994699Polarfix™ Facet Screw SystemCG MedTech Co.,Ltd.FSA45352018-05-17
08800015994705Polarfix™ Facet Screw SystemCG MedTech Co.,Ltd.FSA45402018-05-17
08800015994712Polarfix™ Facet Screw SystemCG MedTech Co.,Ltd.FSA45452018-05-17
08800015994729Polarfix™ Facet Screw SystemCG MedTech Co.,Ltd.FSA45502018-05-17
08800015994736Polarfix™ Facet Screw SystemCG MedTech Co.,Ltd.FSA55252018-05-17
08800015994743Polarfix™ Facet Screw SystemCG MedTech Co.,Ltd.FSA55302018-05-17
08800015994750Polarfix™ Facet Screw SystemCG MedTech Co.,Ltd.FSA55352018-05-17