FDA.reportPublic FDA data

Orthopaedic bone screw starter/notcher

Definition
A hand-held surgical instrument used to create an indentation or enlarge a pre-drilled pilot hole in a bone that will enable the surgeon to begin threading a bone screw or place another form of anchoring device. This device, commonly known as a bone notcher, may function and be used in a variety of ways: 1) notch the bone such that the threads on a bone screw will bite into the bone; 2) simply hold the screw at the desired angle to the bone while the screw is driven into position; or 3) in the case of hard bone (e.g., on the glenoid) be inserted into a pilot hole where it is rotated to create a cavity within the soft bone for placement of, e.g., a suture anchor. This is a reusable device.
GUDID devices
274
Last updated
2026-10-04 01:31:50

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10888857112766MESA Spinal SystemVB Spine LLC5601-900082022-09-23
00763000880248n/aMEDTRONIC SOFAMOR DANEK, INC.79670842025-10-20
00822409099467n/aOrtho Development Corporation852-0005B2023-01-18
10381780279051Universal 2™ Total Wrist Implant SystemAscension Orthopedics, Inc.2605152018-03-09
10381780279068Universal 2™ Total Wrist Implant SystemAscension Orthopedics, Inc.2605202018-03-09
10381780279075Universal 2™ Total Wrist Implant SystemAscension Orthopedics, Inc.2605252018-03-09
10381780279082Universal 2™ Total Wrist Implant SystemAscension Orthopedics, Inc.2605302018-03-09
10381780279099Universal 2™ Total Wrist Implant SystemAscension Orthopedics, Inc.2605352018-03-09
10381780279488K2™ Hemi Toe Implant SystemINTEGRA LIFESCIENCES CORPORATION20310052018-04-10
10381780280194Kompressor™ Compression Screw SystemAscension Orthopedics, Inc.2174122018-04-13
10381780280200Kompressor™ Compression Screw SystemAscension Orthopedics, Inc.2174142018-04-13
10381780280217Kompressor™ Compression Screw SystemAscension Orthopedics, Inc.2174162018-04-13
10381780280224Kompressor™ Compression Screw SystemAscension Orthopedics, Inc.2174182018-04-13
10381780280231Kompressor™ Compression Screw SystemAscension Orthopedics, Inc.2174202018-04-13
10381780280248Kompressor™ Compression Screw SystemAscension Orthopedics, Inc.2174222018-04-13
10381780280255Kompressor™ Compression Screw SystemAscension Orthopedics, Inc.2174242018-04-13
10381780280262Kompressor™ Compression Screw SystemAscension Orthopedics, Inc.2174262018-04-13
10381780280279Kompressor™ Compression Screw SystemAscension Orthopedics, Inc.2174282018-04-13
10381780280286Kompressor™ Compression Screw SystemAscension Orthopedics, Inc.2174302018-04-13
10381780280293Kompressor™ Compression Screw SystemAscension Orthopedics, Inc.2174322018-04-13
10705034004792ISOLADEPUY SPINE, LLC20501252016-12-31
10705034004808ISOLADEPUY SPINE, LLC20501262016-12-31
10705034004877ISOLADEPUY SPINE, LLC20511252016-12-31
10705034199962EXPEDIUMMedos International Sàrl2797297102016-12-31
10705034199979EXPEDIUMMedos International Sàrl2797297202016-12-31
10705034769271NASYNTHES (U.S.A.) LP324.0822016-12-31
10810190016326ISI Tunnel NotcherT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONC2016-09-24
10845854034125GRAFIXConmed CorporationC81062020-09-24
M224INS920510Inion Hexalon instrumentInion Oy12016-08-31
M224INS92059Inion Hexalon instrumentInion Oy02016-08-31
M224INS920610Inion Hexalon instrumentInion Oy12016-08-31
M224INS92069Inion Hexalon instrumentInion Oy02016-08-31
M7161011630OrthoMedFlexORTHOMEDFLEX LLC101-1632016-08-31
10705034001487ISOLADEPUY SPINE, LLC2050542016-12-31
10705034369624PULSEMedos International Sàrl4102102002016-12-31
10705034397320NADEPUY SPINE, LLC6983378752016-11-11
10705034460291NADEPUY SPINE, LLC6983386112016-11-11
10705034460451NADEPUY SPINE, LLC6983398592016-11-11
06438394008755Activa InstrumentBioretec OyB-II-80102026-02-02
03662663161251The Tether Vertebral Body Tethering SystemHighridge Medical, LLC230H10012025-12-15
03662663161268The Tether Vertebral Body Tethering SystemHighridge Medical, LLC230H10022025-12-15
03662663161275The Tether Vertebral Body Tethering SystemHighridge Medical, LLC230H10032025-12-15
03662663161305The Tether Vertebral Body Tethering SystemHighridge Medical, LLC230H20022025-12-15
00842048182405DeGen Standard InstrumentationDEGEN MEDICAL, INC.97-70P2025-08-20
00840124518575TopLockFUSION ORTHOPEDICS, LLCCD-KL-21452025-04-10
00840124518582TopLockFUSION ORTHOPEDICS, LLCCD-KT-26452025-04-10
00840124513228TopLockFUSION ORTHOPEDICS, LLCCD-KT-2535-S2024-07-22
00840124513235TopLockFUSION ORTHOPEDICS, LLCCD-KT-2545-S2024-07-22
10705034201030EXPEDIUMDEPUY SPINE, LLC2797636002016-12-31
06009712642885DoubleTapORTHO-DESIGN (PTY) LTDADP009-22024-06-24
06009712642892VersaPEEK Tapping ToolORTHO-DESIGN (PTY) LTDAPP001-22024-06-24
00840124511521TopLockFUSION ORTHOPEDICS, LLCCD-KL-20352024-04-26
00840124511538TopLockFUSION ORTHOPEDICS, LLCCD-KL-20452024-04-26
00840124511545TopLockFUSION ORTHOPEDICS, LLCCD-KT-25452024-04-26
00840124511552TopLockFUSION ORTHOPEDICS, LLCCD-KT-25352024-04-26
M24820310051K2™ Hemi Toe Implant SystemINTEGRA LIFESCIENCES CORPORATION20310052018-04-10
10885403203435V. MuellerSTERIS CORPORATIONOS15442018-09-10
10885403204180V. MuellerSTERIS CORPORATIONOS7000-0112018-09-10
10885403204197V. MuellerSTERIS CORPORATIONOS7000-0152018-09-10
10885403204203V. MuellerSTERIS CORPORATIONOS7000-0202018-09-10
10705034211336EXPEDIUMMedos International Sàrl2862300202016-12-31
06009712642458DoubleTapORTHO-DESIGN (PTY) LTDADP009-12023-09-07
06009712642663VersaPEEK TapORTHO-DESIGN (PTY) LTDAPP001-12023-09-07
10885403204210V. MuellerSTERIS CORPORATIONOS7000-0252018-09-10
10885403204227V. MuellerSTERIS CORPORATIONOS7000-0272018-09-10
10885403204234V. MuellerSTERIS CORPORATIONOS7000-0322018-09-10
10885403204241V. MuellerSTERIS CORPORATIONOS7000-0332018-09-10
10885403204258V. MuellerSTERIS CORPORATIONOS7000-0352018-09-10
10885403204265V. MuellerSTERIS CORPORATIONOS7000-0362018-09-10
10885403204272V. MuellerSTERIS CORPORATIONOS7000-0452018-09-10
10885403204289V. MuellerSTERIS CORPORATIONOS7000-0602018-09-10
10885403204296V. MuellerSTERIS CORPORATIONOS7010-0112018-09-10
10885403204302V. MuellerSTERIS CORPORATIONOS7010-0152018-09-10
10885403204319V. MuellerSTERIS CORPORATIONOS7010-0202018-09-10
10885403204326V. MuellerSTERIS CORPORATIONOS7010-0252019-02-06
10885403204333V. MuellerSTERIS CORPORATIONOS7010-0272018-09-10
10885403204340V. MuellerSTERIS CORPORATIONOS7010-0322018-09-10
10885403204357V. MuellerSTERIS CORPORATIONOS7010-0332018-09-10
10885403204364V. MuellerSTERIS CORPORATIONOS7010-0352018-09-10
10885403204371V. MuellerSTERIS CORPORATIONOS7010-0362018-09-10