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
163
Last updated
2026-10-06 03:50:11

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
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
04250337100232TESSYS®Joimax GmbHCRC2155652022-12-30
04250337100249TESSYS®Joimax GmbHCRC2165752022-12-30
04250337100256TESSYS®Joimax GmbHCRC2175852022-12-30
04250337100263TESSYS®Joimax GmbHCRF2132402022-12-30
04250337100270TESSYS®Joimax GmbHCRF2142502022-12-30
04250337100287TESSYS®Joimax GmbHCRF2155652022-12-30
04250337100294TESSYS®Joimax GmbHCRF2165752022-12-30
04250337100300TESSYS®Joimax GmbHCRF2175852022-12-30
04250337101215TESSYS®Joimax GmbHTER3528352022-12-30
04250337105145CESSYS®Joimax GmbHCER1128352022-12-30
10381780045045PANTA®NEWDEAL519010ND2017-05-26
10381780045052PANTA®NEWDEAL519011ND2017-05-26
10381780045069PANTA®NEWDEAL519012ND2017-05-26
10381780045076PANTA®NEWDEAL519013ND2017-05-26
10381780045083PANTA®NEWDEAL519014ND2017-05-26
10381780045090PANTA®NEWDEAL519015ND2017-05-26
10381780045106PANTA®NEWDEAL519016ND2017-05-26
10381780045113PANTA®NEWDEAL519017ND2017-05-26
10381780045601PANTA®NEWDEAL539020ND2017-05-26
10381780045618PANTA®NEWDEAL539021ND2017-05-26
10381780045625PANTA®NEWDEAL539022ND2017-05-26
10381780045632PANTA®NEWDEAL539023ND2017-05-26
10705034731582NASYNTHES (U.S.A.) LP03.820.117S2018-07-19
10705034731827NASYNTHES (U.S.A.) LP03.820.153S2018-07-19
10705034731834NASYNTHES (U.S.A.) LP03.820.157S2018-07-19
10705034731858NASYNTHES (U.S.A.) LP03.820.161S2018-07-19
10705034731865NASYNTHES (U.S.A.) LP03.820.163S2018-07-19
10705034731872NASYNTHES (U.S.A.) LP03.820.167S2018-07-19
10705034731889NASYNTHES (U.S.A.) LP03.820.169S2018-07-19
10845854017203Concept GrafixConmed CorporationCR88472021-10-15
10845854019122C-REAMERConmed Corporation8772A2020-12-13