FDA.reportPublic FDA data

Bone-resection orthopaedic reamer, single-use

Definition
An orthopaedic surgical instrument designed to resect bone (cut out part of the bone) and precisely shape a specific area of bone as it is advanced for the acceptance of a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna). Commonly called a mill or a reamer it is typically designed as either a preshaped or a solid cylindrical body with an end/circumferential cutting edge, and is attached to a shaft for manual or powered rotation. It is typically made of a high-grade stainless steel alloy available in varying sizes. This is a single-use device.
GUDID devices
153
Last updated
2023-07-24 06:53:31

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00819034029181Sgarlato SilasticFUSION ORTHOPEDICS, LLC30-301-51-S2023-07-14
00819034029198Sgarlato SilasticFUSION ORTHOPEDICS, LLC30-301-52-S2023-07-14
00840124507456Sgarlato SilasticFUSION ORTHOPEDICS, LLC70-095-012023-07-14
00840124508989Sgarlato SilasticFUSION ORTHOPEDICS, LLC70-095-01-S2023-07-14
00840124502260FuzeRightFUSION ORTHOPEDICS, LLCHT-60-8000-S2023-07-03
00840124507609PolyLock SmallBoneFUSION ORTHOPEDICS, LLCCD-TB-70002023-06-12
00888867405493Arthrex®ARTHREX, INC.AR-8904CR2023-06-05
00888867405509Arthrex®ARTHREX, INC.AR-8904HR2023-06-05
00888867409743Arthrex®ARTHREX, INC.AR-5410-AMGS-S2023-04-24
00888867409750Arthrex®ARTHREX, INC.AR-5410-AMGS-M2023-04-24
00888867409767Arthrex®ARTHREX, INC.AR-5410-AMGS-L2023-04-24
00850022768170RAZOR Calcar PlanerRazor Medical Instruments, Inc.1102-0038-P2023-04-05
00840097506340restor3d Disposable InstrumentRestor3d, Inc.6200-182023-04-03
00840097506357restor3d Disposable InstrumentRestor3d, Inc.6200-202023-04-03
00840097506364restor3d Disposable InstrumentRestor3d, Inc.6200-222023-04-03
00889797101233ORTHOLOC 3DiWRIGHT MEDICAL TECHNOLOGY, INC.58A920162022-09-29
00889797101240ORTHOLOC 3DiWRIGHT MEDICAL TECHNOLOGY, INC.58A920182022-09-29
00889797101257ORTHOLOC 3DiWRIGHT MEDICAL TECHNOLOGY, INC.58A920202022-09-29
00889797101264ORTHOLOC 3DiWRIGHT MEDICAL TECHNOLOGY, INC.58A920222022-09-29
08057968717510ACETABULAR REAMER EVO 2 Ti CUP D66 mm HPF SRLH00385566992022-09-06
08057968717800ACETABULAR REAMER EVO 2 Ti CUP D64 mm HPF SRLH00385564992022-09-06
08057968717817ACETABULAR REAMER EVO 2 Ti CUP D65 mmHPF SRLH00385565992022-09-06
08057968717824ACETABULAR REAMER EVO 2 Ti CUP D67 mm HPF SRLH00385567992022-09-06
08057968717831ACETABULAR REAMER EVO 2 Ti CUP D68 mm HPF SRLH00385568992022-09-06
08057968717848ACETABULAR REAMER EVO 2 Ti CUP D69 mm HPF SRLH00385569992022-09-06
08057968717855ACETABULAR REAMER EVO 2 Ti CUP D70 mm HPF SRLH00385570992022-09-06
08057968717862ACETABULAR REAMER EVO 2 Ti CUP D71 mm HPF SRLH00385571992022-09-06
08057968717879ACETABULAR REAMER EVO 2 Ti CUP D72 mm HPF SRLH00385572992022-09-06
08057968717886ACETABULAR REAMER EVO 2 Ti CUP D73 mm HPF SRLH00385573992022-09-06
08057968717893ACETABULAR REAMER EVO 2 Ti CUP D74 mm HPF SRLH00385574992022-09-06
08057968717909ACETABULAR REAMER EVO 2 Ti CUP D75 mm HPF SRLH00385575992022-09-06
08057968717916ACETABULAR REAMER EVO 2 Ti CUP D76 mm HPF SRLH00385576992022-09-06
08057968717923ACETABULAR REAMER EVO 2 Ti CUP D77 mm HPF SRLH00385577992022-09-06
08057968717930ACETABULAR REAMER EVO 2 Ti CUP D78 mm HPF SRLH00385578992022-09-06
08057968717947ACETABULAR REAMER EVO 2 Ti CUP D79 mm HPF SRLH00385579992022-09-06
08057968717954ACETABULAR REAMER EVO 2 Ti CUP D80 mm HPF SRLH00385580992022-09-06
08057968717671ACETABULAR REAMER EVO 2 Ti CUP D51 mm HPF SRLH00385551992022-08-31
08057968717688ACETABULAR REAMER EVO 2 Ti CUP D52 mmHPF SRLH00385552992022-08-31
08057968717695ACETABULAR REAMER EVO 2 Ti CUP D53 mm HPF SRLH00385553992022-08-31
08057968717701ACETABULAR REAMER EVO 2 Ti CUP D54 mm HPF SRLH00385554992022-08-31
08057968717718ACETABULAR REAMER EVO 2 Ti CUP D55 mm HPF SRLH00385555992022-08-31
08057968717725ACETABULAR REAMER EVO 2 Ti CUP D56 mm HPF SRLH00385556992022-08-31
08057968717732ACETABULAR REAMER EVO 2 Ti CUP D57 mm HPF SRLH00385557992022-08-31
08057968717749ACETABULAR REAMER EVO 2 Ti CUP D58 mm HPF SRLH00385558992022-08-31
08057968717756ACETABULAR REAMER EVO 2 Ti CUP D59 mm HPF SRLH00385559992022-08-31
08057968717763ACETABULAR REAMER EVO 2 Ti CUP D60 mmHPF SRLH00385560992022-08-31
08057968717770ACETABULAR REAMER EVO 2 Ti CUP D61 mm HPF SRLH00385561992022-08-31
08057968717787ACETABULAR REAMER EVO 2 Ti CUP D62 mmHPF SRLH00385562992022-08-31
08057968717794ACETABULAR REAMER EVO 2 Ti CUP D63 mm HPF SRLH00385563992022-08-31
08057968717527ACETABULAR REAMER EVO 2 Ti CUP D36 mm HPF SRLH00385536992022-08-25
08057968717534ACETABULAR REAMER EVO 2 Ti CUP D37 mm HPF SRLH00385537992022-08-25
08057968717541ACETABULAR REAMER EVO 2 Ti CUP D38 mm HPF SRLH00385538992022-08-25
08057968717558ACETABULAR REAMER EVO 2 Ti CUP D39 mm HPF SRLH00385539992022-08-25
08057968717565ACETABULAR REAMER EVO 2 Ti CUP D40 mm HPF SRLH00385540992022-08-25
08057968717572ACETABULAR REAMER EVO 2 Ti CUP D41 mm HPF SRLH00385541992022-08-25
08057968717589ACETABULAR REAMER EVO 2 Ti CUP D42 mm HPF SRLH00385542992022-08-25
08057968717596ACETABULAR REAMER EVO 2 Ti CUP D43 mm HPF SRLH00385543992022-08-25
08057968717602ACETABULAR REAMER EVO 2 Ti CUP D44 mmHPF SRLH00385544992022-08-25
08057968717619ACETABULAR REAMER EVO 2 Ti CUP D45 mmHPF SRLH00385545992022-08-25
08057968717626ACETABULAR REAMER EVO 2 Ti CUP D46 mm HPF SRLH00385546992022-08-25
08057968717633ACETABULAR REAMER EVO 2 Ti CUP D47 mm HPF SRLH00385547992022-08-25
08057968717640ACETABULAR REAMER EVO 2 Ti CUP D48 mm HPF SRLH00385548992022-08-25
08057968717657ACETABULAR REAMER EVO 2 Ti CUP D49 mm HPF SRLH00385549992022-08-25
08057968717664ACETABULAR REAMER EVO 2 Ti CUP D50 mm HPF SRLH00385550992022-08-25
00888867271548Arthrex®ARTHREX, INC.ABS-1101-10S2022-08-10
00888867271555Arthrex®ARTHREX, INC.ABS-1101-20S2022-08-10
00888867271562Arthrex®ARTHREX, INC.ABS-1102-19S2022-08-10
00888867271579Arthrex®ARTHREX, INC.ABS-1102-25S2022-08-10
0085003286900346mm Single-Use Acetabular ReamerOsteofit LLC11-100-00462022-08-04
0085003286901048mm Single-Use Acetabular ReamerOsteofit LLC11-100-00482022-08-04
0085003286902750mm Single-Use Acetabular ReamerOsteofit LLC11-100-00502022-08-04
0085003286903452mm Single-Use Acetabular ReamerOsteofit LLC11-100-00522022-08-04
0085003286904154mm Single-Use Acetabular ReamerOsteofit LLC11-100-00542022-08-04
0085003286905856mm Single-Use Acetabular ReamerOsteofit LLC11-100-00562022-08-04
0085003286906558mm Single-Use Acetabular ReamerOsteofit LLC11-100-00582022-08-04
00811714034836FalconRESPONSIVE ORTHOPEDICS LLC907001-07002022-03-16
00811714034843FalconRESPONSIVE ORTHOPEDICS LLC907001-07502022-03-16
00811714034850FalconRESPONSIVE ORTHOPEDICS LLC907001-08002022-03-16
00811714034867FalconRESPONSIVE ORTHOPEDICS LLC907001-08502022-03-16
00811714034874FalconRESPONSIVE ORTHOPEDICS LLC907001-09002022-03-16