FDA.reportPublic FDA data

Bone-resection orthopaedic reamer, single-use

Definition
An orthopaedic surgical instrument intended to resect bone (cut out part of the bone), and in some cases hypertrophic tissue [e.g., ligamentum flavum], to: 1) accept a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna); and/or 2) relieve pressure at or facilitate access to a joint. Commonly called a mill or a reamer, it is typically designed as a stainless steel cylindrical body with an end/circumferential cutting edge and is attached to a shaft for manual or powered rotation. This is a single-use device.
GUDID devices
193
Last updated
2026-10-13 01:10:32

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00815432023080MotoBANDCROSSROADS EXTREMITY SYSTEMSMotoBAND CP 2.5mm Reamer - Sterile2016-05-10
00815432023790DynaFORCE™CROSSROADS EXTREMITY SYSTEMS2.2mm Staple Reamer2020-01-07
00815432023806DynaFORCE™CROSSROADS EXTREMITY SYSTEMS2.5mm Staple Reamer2020-01-07
00815432023813DynaFORCE™CROSSROADS EXTREMITY SYSTEMS2.7mm Staple Reamer2020-01-07
00815432023820DynaFORCE™CROSSROADS EXTREMITY SYSTEMS3.0mm Staple Reamer2020-01-07
00815432023837DynaFORCE™CROSSROADS EXTREMITY SYSTEMS3.2mm Staple Reamer2020-01-07
00815432027200MotoBAND™ CP DynaForce®CROSSROADS EXTREMITY SYSTEMSDynaForce Reamer, 2.5mm Sterile Packaged2019-04-16
00815432027224MotoBAND™ CP DynaForce®CROSSROADS EXTREMITY SYSTEMSDynaForce Long Reamer, 2.5mm Sterile Packaged2019-04-16
00815432028061MotoBAND CP DynaFORCE™CROSSROADS EXTREMITY SYSTEMSPlate Benders2020-03-20
00815432028078MotoBAND CP DynaFORCE™CROSSROADS EXTREMITY SYSTEMSK-wires, 1.6mm2020-03-19
00815432028085MotoBAND CP DynaFORCE™CROSSROADS EXTREMITY SYSTEMSOlive Wires2020-03-19
00815432028269MotoBAND CP DynaFORCE™CROSSROADS EXTREMITY SYSTEMSDynaBunion Reducer - Track2020-05-15
00815432028276MotoBAND CP DynaFORCE™CROSSROADS EXTREMITY SYSTEMSDynaBunion Reducer - Lateral Hook2020-05-15
00815432028283MotoBAND CP DynaFORCE™CROSSROADS EXTREMITY SYSTEMSDynaBunion Reducer Knob2020-05-15
00815432028290MotoBAND CP DynaFORCE™CROSSROADS EXTREMITY SYSTEMSDynaBunion Cut Guide2020-05-15
00815432028306MotoBAND CP DynaFORCE™CROSSROADS EXTREMITY SYSTEMSDynaBunion Joystick2020-05-15
00815432028313MotoBAND CP DynaFORCE™CROSSROADS EXTREMITY SYSTEMSCompressor Block2020-05-15
00815432028337MotoBAND CP DynaFORCE™CROSSROADS EXTREMITY SYSTEMSCompressor Block - PLUS2020-05-15
00815432028344MotoBAND CP DynaFORCE™CROSSROADS EXTREMITY SYSTEMSWire Template2020-05-15
00815432028351MotoBAND CP DynaFORCE™CROSSROADS EXTREMITY SYSTEMSAnti-Drift Drill Guide2020-05-15
00815432028382MotoBAND CP DynaFORCE™CROSSROADS EXTREMITY SYSTEMSUniversal Handle2020-05-15
00815432028764MotoBAND CP DynaFORCE™CROSSROADS EXTREMITY SYSTEMS2.0mm x 4inch k-wire2020-05-12
00815432028771MotoBAND CP DynaFORCE™CROSSROADS EXTREMITY SYSTEMS2.0mm x 6inch k-wire2020-05-12
00815432028917MotoBAND™ CP DynaForce®CROSSROADS EXTREMITY SYSTEMSAnti-Drift Bolt Reamer Kit Pack-Out2020-05-28
00815432029242MotoBAND CP DynaFORCE™CROSSROADS EXTREMITY SYSTEMSMotoBAND CP Large Benders2021-05-20
00815432028320MotoBAND CP DynaFORCE™CROSSROADS EXTREMITY SYSTEMSCompressor Block Size 12020-10-22
00815432028931MotoBAND CP DynaFORCE™CROSSROADS EXTREMITY SYSTEMSCompressor Block, Size 32020-10-22
00815432029037MotoBAND CP DynaFORCE™CROSSROADS EXTREMITY SYSTEMSLapidus Re-Cut Guide2020-10-22
00850038154301DynaForceCROSSROADS EXTREMITY SYSTEMS1500-SPSK2023-01-30
00850038154646DynaBunionCROSSROADS EXTREMITY SYSTEMSIMA Reducer - Disposable2024-05-01
00850310006434CrossTIE™ Reamer 2.2mmCROSSROADS EXTREMITY SYSTEMS1400-10222023-01-05
00843193102447Prodisc C InstrumentCentinel Spine, LLC03.820.117S2026-09-25
00843193102454Prodisc C, SK, Vivo, Nova InstrumentCentinel Spine, LLC03.820.161S2026-09-25
00843193102461Prodisc C InstrumentCentinel Spine, LLC03.820.153S2026-09-25
00843193102478Prodisc C InstrumentCentinel Spine, LLC03.820.163S2026-09-25
00843193102485Prodisc C InstrumentCentinel Spine, LLC03.820.157S2026-09-25
00843193102492Prodisc C InstrumentCentinel Spine, LLC03.820.167S2026-09-25
00843193102508Prodisc C InstrumentCentinel Spine, LLC03.820.159S2026-09-25
00843193102515Prodisc C InstrumentCentinel Spine, LLC03.820.169S2026-09-25
00843193115706Prodisc C InstrumentCentinel Spine, LLCIN1545S2026-09-25
00843193115713Prodisc C InstrumentCentinel Spine, LLCIN1546S2026-09-25
10888857261693PYRENEES® Cervical Plate SystemVB Spine LLC6808-900162021-03-25
10888857261716PYRENEES® Cervical Plate SystemVB Spine LLC6808-900182021-03-25
10888857261723PYRENEES® Cervical Plate SystemVB Spine LLC6808-900192021-03-25
00810111226769ReamerTreace Medical Concepts, Inc.SN502026-05-01
00810111226776ReamerTreace Medical Concepts, Inc.SN512026-05-01
00810111226783ReamerTreace Medical Concepts, Inc.SN522026-05-01
00810190980811Eleganz Fusion Screw SystemDev4DI-20322025-10-01
00810190980828Eleganz Fusion Screw SystemDev4DI-20332025-10-01
00810190981436Eleganz IM Threaded NailDev4MI-25012026-04-23
00810190981443Eleganz IM Threaded NailDev4MI-35012026-04-23
00810190981450Eleganz IM Threaded NailDev4MI-45012026-04-23
00840124516519FibFixFUSION ORTHOPEDICS, LLCCD-FN-10372026-04-09
00840124516526FibFixFUSION ORTHOPEDICS, LLCCD-FN-10472026-04-09
00840124516533FibFixFUSION ORTHOPEDICS, LLCCD-FN-10572026-04-09
00840124516540FibFixFUSION ORTHOPEDICS, LLCCD-FN-15372026-04-09
00840124516557FibFixFUSION ORTHOPEDICS, LLCCD-FN-15472026-04-09
00840124516564FibFixFUSION ORTHOPEDICS, LLCCD-FN-15572026-04-09
00840124516595FibFixFUSION ORTHOPEDICS, LLCCD-FN-10662026-04-09
00840124517523FibFixFUSION ORTHOPEDICS, LLCCD-FN-1037-S2026-04-09
00840124517530FibFixFUSION ORTHOPEDICS, LLCCD-FN-1047-S2026-04-09
00840124517547FibFixFUSION ORTHOPEDICS, LLCCD-FN-1057-S2026-04-09
00840124517554FibFixFUSION ORTHOPEDICS, LLCCD-FN-1537-S2026-04-09
00840124517561FibFixFUSION ORTHOPEDICS, LLCCD-FN-1547-S2026-04-09
00840124517578FibFixFUSION ORTHOPEDICS, LLCCD-FN-1557-S2026-04-09
00840124517608FibFixFUSION ORTHOPEDICS, LLCCD-FN-1066-S2026-04-09
00840124521261FibFixFUSION ORTHOPEDICS, LLCCD-FN-4000-S2026-04-09
00840124521711FuzeFix Static NailFUSION ORTHOPEDICS, LLCCD-SC-20252025-09-30
00840124521735FuzeFix Static NailFUSION ORTHOPEDICS, LLCCD-SC-20302025-09-30
00840124521742FuzeFix Static NailFUSION ORTHOPEDICS, LLCCD-SC-20352025-09-30
00840124521759FuzeFix Static NailFUSION ORTHOPEDICS, LLCCD-SC-20402025-09-30
00840124524248FuzeFix Max FTFUSION ORTHOPEDICS, LLCCD-SC-20202025-10-22
00841731135247Redemption VILEX LLCRD-REAM-13E2026-01-12
00841731135254Redemption VILEX LLCRD-REAM-ST2026-01-12
00850023741110CER-RMR-8RANFAC CORP."8GA X 7"""2021-03-05
00850023741127CER-RMR-11RANFAC CORP."11GA X 8.4"""2021-03-05
00889795141293Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.P32-959-01102025-11-19
00889795141316Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.P32-959-01452025-11-19
00889795142627Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.P32-959-STRQ-S2025-11-19
00889795146311Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.P32-959-01602025-11-19