FDA.reportPublic FDA data

Orthopaedic osteotome handle

Definition
A hand-held component of an orthopaedic osteotome intended to be attached to an interchangeable blade (not included) to become a chisel-like surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. The operator holds this part of the instrument and manually imparts a force to it using a surgical mallet or hammer; it is made of metal and/or polymer materials. This is a reusable device.
GUDID devices
188
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00192896102149MeniscotomeSONTEC INSTRUMENTS, INC.350-8362020-06-01
00197157081287ZAVATION T-HANDLEZavation LLCZ-10792026-05-14
00840124522091FuzeFix MiniFUSION ORTHOPEDICS, LLCTN-FX-69502025-10-16
00840124525498HandleFUSION ORTHOPEDICS, LLCTN-HN-60132026-03-18
00840124525504HandleFUSION ORTHOPEDICS, LLCTN-HN-60122026-03-18
00840124525511HandleFUSION ORTHOPEDICS, LLCTN-HN-60112026-03-18
00840124525528HandleFUSION ORTHOPEDICS, LLCTN-HN-60142026-04-09
00840124525320FuzeFix MiniFUSION ORTHOPEDICS, LLCTN-FX-60122026-02-03
00840124525337FuzeFix MiniFUSION ORTHOPEDICS, LLCTN-FX-60132026-02-03
00840124525245FuzeFix MiniFUSION ORTHOPEDICS, LLCTN-FX-60112026-01-22
00840124518759FuzeFix MiniFUSION ORTHOPEDICS, LLCTN-FX-60102025-05-13
00840124518766FuzeFix MiniFUSION ORTHOPEDICS, LLCTN-FX-60202025-05-13
00197157021078Zavation HDL, FXD, BALLZavation LLCZ-10632024-09-06
08720254007007KINCISE™ System Acetabular Cup Extraction ShaftSpierings Orthopaedics B.V.KIN-2110-012024-03-19
M7403120050OptiMesh Multiplanar Expandable Interbody Fusion SystemSPINEOLOGY INC.35-06-812023-09-14
M7403120053OptiMesh Multiplanar Expandable Interbody Fusion SystemSPINEOLOGY INC.35-06-822023-09-14
M743120050OptiMesh Multiplanar Expandable Interbody Fusion SystemSPINEOLOGY INC.35-06-812023-09-14
M743120053OptiMesh Multiplanar Expandable Interbody Fusion SystemSPINEOLOGY INC.35-06-822023-09-14
00819034026159FuzeFix LargeFUSION ORTHOPEDICS, LLCTN-FX-60402023-06-16
00819034026166FuzeFix LargeFUSION ORTHOPEDICS, LLCTN-FX-60502023-06-16
00840124501805FuzeFix MiniFUSION ORTHOPEDICS, LLCTN-FX-60102023-06-15
00840124501812FuzeFix MiniFUSION ORTHOPEDICS, LLCTN-FX-60202023-06-15
00840124507555PolyLock SmallBone FUSION ORTHOPEDICS, LLCTN-TB-70022023-06-09
00840124507562PolyLock SmallBoneFUSION ORTHOPEDICS, LLCTN-TB-70032023-06-09
00840124507579PolyLock SmallBoneFUSION ORTHOPEDICS, LLCTN-TB-70042023-06-09
00850032955386RP MedicalRP Medical Inc39.1960.022023-05-10
00197169170016Watson Extraction SystemDEPUY (IRELAND)170012023-03-04
B756SHN0470Shukla Shoulder Blade S9SHLDR-BLADEShukla MedicalSHN0472022-08-01
B756SHN0540Shukla Shoulder S9SHLDRShukla MedicalSHN0542022-08-01
00840319707807Hayden MedicalHayden Medical, Inc.270-8042022-07-28
00840319707814Hayden MedicalHayden Medical, Inc.270-8052022-07-28
00840319707821Hayden MedicalHayden Medical, Inc.270-8062022-07-28
00850032955171RP MedicalRP Medical Inc39.1960.012021-12-31
B756SHN0120Shukla Blade S9BLADEShukla MedicalSHN0122021-07-15
B582080100010N/AGEORGE TIEMANN & CO.080100012020-09-24
B582080102010N/AGEORGE TIEMANN & CO.080102012020-09-24
B582080107520N/AGEORGE TIEMANN & CO.080107522020-09-24
B582080107540N/AGEORGE TIEMANN & CO.080107542020-09-24
B582080822120N/AGEORGE TIEMANN & CO.80822122020-09-24
B582080822140N/AGEORGE TIEMANN & CO.080822142020-09-24
B582080822180N/AGEORGE TIEMANN & CO.080822182020-09-24
B582080822380N/AGEORGE TIEMANN & CO.080822382020-09-24
B582080823120N/AGEORGE TIEMANN & CO.080823122020-09-24
B582080823140N/AGEORGE TIEMANN & CO.080823142020-09-24
B582080823180N/AGEORGE TIEMANN & CO.080823182020-09-24
B582080823340N/AGEORGE TIEMANN & CO.080823342020-09-24
B582080823380N/AGEORGE TIEMANN & CO.080823382020-09-24
B58208084010N/AGEORGE TIEMANN & CO.08084012020-09-24
B582080840120N/AGEORGE TIEMANN & CO.080840122020-09-24
B582080840340N/AGEORGE TIEMANN & CO.080840342020-09-24
B582080841120N/AGEORGE TIEMANN & CO.080841122020-09-24
B582080841340N/AGEORGE TIEMANN & CO.080841342020-09-24
B582080841X140N/AGEORGE TIEMANN & CO.080841X142020-09-24
B582080842340N/AGEORGE TIEMANN & CO.080842342020-09-24
B582080843140N/AGEORGE TIEMANN & CO.080843142020-09-24
B582080880120N/AGEORGE TIEMANN & CO.080880122020-09-24
B582080880340N/AGEORGE TIEMANN & CO.080880342020-09-24
B58280815380N/AGEORGE TIEMANN & CO.808153/82020-09-24
B582808270N/AGEORGE TIEMANN & CO.808272020-09-24
B58280925120N/AGEORGE TIEMANN & CO.80925122020-09-24
B5828092580N/AGEORGE TIEMANN & CO.8092582020-09-24
B58203012560N/AGEORGE TIEMANN & CO.03012562020-09-24
B58203012570N/AGEORGE TIEMANN & CO.03012572020-09-24
B5820801010N/AGEORGE TIEMANN & CO.B58208010102020-09-24
B582081242N/AGEORGE TIEMANN & CO.0812422020-09-24
B582081243N/AGEORGE TIEMANN & CO.0812432020-09-24
B5820839040N/AGEORGE TIEMANN & CO.B58208390402020-09-24
B5820839350N/AGEORGE TIEMANN & CO.B58208393502020-09-24
B582086BB190N/AGEORGE TIEMANN & CO.B582086BB1902020-09-24
B5828010201120N/AGEORGE TIEMANN & CO.8010201122020-09-24
B5828010201140N/AGEORGE TIEMANN & CO.8010201142020-09-24
B582801020140N/AGEORGE TIEMANN & CO.801020142020-09-24
B582801020340N/AGEORGE TIEMANN & CO.801020342020-09-24
B582801020380N/AGEORGE TIEMANN & CO.801020382020-09-24
B582801025140N/AGEORGE TIEMANN & CO.801025142020-09-24
B582801025340N/AGEORGE TIEMANN & CO.801025342020-09-24
B582801025380N/AGEORGE TIEMANN & CO.801025382020-09-24
B582801025580N/AGEORGE TIEMANN & CO.801025582020-09-24
B582801025780N/AGEORGE TIEMANN & CO.801025782020-09-24
B582801090100N/AGEORGE TIEMANN & CO.801090102020-09-24