FDA.report

Osteotomy guide, single-use

Definition
A surgical instrument intended to be attached to a bone (e.g., pelvis, femur, tibia, ulna) during an osteotomy procedure (including during joint arthroplasty) to outline/define the desired cut-line and mechanically support/guide the cutting device (e.g., oscillating cutting saw). This is a single-use device.
GUDID devices
31
Last updated
2025-01-20 09:52:53

Related Product Codes

CodeDeviceSpecialtyClassDevices
OYKAnkle Arthroplasty Implantation SystemOrthopedic216
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery19
HTZInstrument, Cutting, OrthopedicGeneral, Plastic Surgery15
LPHProsthesis, Hip, Semi-Constrained, Metal/Polymer, Porous UncementedOrthopedic21
LXHOrthopedic Manual Surgical InstrumentOrthopedic11

Representative GUDID Devices

Primary DIBrandCompanyModelPublished
00816847022736Salto Talaris Flat Cut Total Ankle System3D SYSTEMS, INC.Tibia Cutting Guide2025-01-10
00816847022743Salto Talaris Flat Cut Total Ankle System3D SYSTEMS, INC.Talus Cutting Guide2025-01-10
00816847022767Cadence Flat Cut Total Ankle System3D SYSTEMS, INC.Talus Cutting Guide2025-01-10
00816847022774Cadence Flat Cut Total Ankle System3D SYSTEMS, INC.Tibia Cutting Guide2025-01-10
03700569648244Newclip InstrumentsNEWCLIP TECHNICSANC10152024-11-07
00816847022699Salto Talaris Chamfer Cut Total Ankle System3D SYSTEMS, INC.Talus Cutting Guide2024-09-12
00816847022705Salto Talaris Chamfer Cut Total Ankle System3D SYSTEMS, INC.Tibia Cutting Guide2024-09-12
00816847022712Cadence Chamfer Cut Total Ankle System3D SYSTEMS, INC.Talus Cutting Guide2024-09-12
00816847022729Cadence Chamfer Cut Total Ankle System3D SYSTEMS, INC.Tibia Cutting Guide2024-09-12
00840097509914restor3d Kinos Axiom PSR Restor3d5831-90032023-09-27
00840097509921restor3d Kinos Axiom PSR Restor3d5831-90042023-09-27
00840097509938restor3d Kinos Axiom PSR Restor3d5831-90052023-09-27
00840097509945restor3d Kinos Axiom PSR Restor3d5831-90062023-09-27
00840097508924restor3d Kinos Axiom PSR Restor3d5831-90012023-05-01
00840097508931restor3d Kinos Axiom PSR Restor3d5831-90022023-05-01
00840097508948restor3d Kinos Axiom PSR Restor3d5831-90032023-05-01
00840097508955restor3d Kinos Axiom PSR Restor3d5831-9102023-05-01
B278PVGUIDE04N0My3D® Personalized Pelvic Reconstruction ONKOS SURGICAL, INC.PV-GUIDE-04N2023-02-22
00850038154226DynaBunionCROSSROADS EXTREMITY SYSTEMS1500-48FH2022-08-02
B562OGSCA550Exact Osteotomy SystemWISHBONE MEDICAL, INC.OGS-CA552021-09-16
B562OGSDMAA0Exact Osteotomy SystemWISHBONE MEDICAL, INC.OGS-DMAA2021-09-16
B562OGSLA450Exact Osteotomy SystemWISHBONE MEDICAL, INC.OGS-LA452021-09-16
B562OGSPDG20Exact Osteotomy SystemWISHBONE MEDICAL, INC.OGS-PDG22021-09-16
B562OGSSCZG0Exact Osteotomy SystemWISHBONE MEDICAL, INC.OGS-SCZG2021-09-16
B562OGSYWG10Exact Osteotomy SystemWISHBONE MEDICAL, INC.OGS-YWG12021-09-16
B562OGSYWG20Exact Osteotomy SystemWISHBONE MEDICAL, INC.OGS-YWG22021-09-16
B562OGSYWG30Exact Osteotomy SystemWISHBONE MEDICAL, INC.OGS-YWG32021-09-16
00888867350991Arthrex®ARTHREX, INC.AR-621-TL2020-12-14
00888867351004Arthrex®ARTHREX, INC.AR-621-TL22020-12-14
00888867351011Arthrex®ARTHREX, INC.AR-621-TR2020-12-14
00888867351028Arthrex®ARTHREX, INC.AR-621-TR22020-12-14