FDA.reportPublic FDA data

Chisel/osteotome blade handle

Definition
A hand-held manual surgical device that is an interchangeable component of a chisel or osteotome blade and that functions as a handle designed to mount a compatible blade of these types which is locked into place. Together, this device and the selected blade, become a single-bladed surgical instrument used by a physician for cutting/contouring bone. This is a reusable device.
GUDID devices
121
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
04250407717148FENTEXFENTEX medical GmbH164200FX2022-12-08
04250407717155FENTEXFENTEX medical GmbH164300FX2022-12-08
04250407742317FENTEXFENTEX medical GmbH532125FX2022-12-12
08800000945736Ridge Split Blade HolderOsstem Implant Co., Ltd.ORSBH2022-12-08
08800053083140OsteotomeDENTIS CO. ,LTDDSSO35R2026-04-22
08800053083157OsteotomeDENTIS CO. ,LTDDSSO42R2026-04-22
08800053083164OsteotomeDENTIS CO. ,LTDDSSO35S2026-04-22
08800053083171OsteotomeDENTIS CO. ,LTDDSSO42S2026-04-22
08800209371985Ridge Split Blade HolderOsstem Implant Co., Ltd.HRSBH2022-12-08
10603295123071MORELANDDEPUY ORTHOPAEDICS, INC.2422-10-0002018-09-24
10649111224478Sklar®SKLAR CORPORATION49-35502018-12-03
03662663109215Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLC07.00845.0022026-02-11
03662663109222Trinica/Trinica Select Anterior Cervical Plate SystemHighridge Medical, LLC07.00845.0032026-02-11
00888480597391Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCLV008162025-11-16
00888480597407Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCLV008172025-11-16
00888480597421Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCLV008192025-11-16
00888480597438Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCLV008202025-11-16
04049197188180RZ Medizintechnik GmbHRZ-Medizintechnik GmbH259-210-0052024-06-28
04049197188265RZ Medizintechnik GmbHRZ-Medizintechnik GmbH259-211-0052024-06-28
04049197205450RZ Medizintechnik GmbHRZ-Medizintechnik GmbH290-151-2402024-06-28
04049197304658RZ Medizintechnik GmbHRZ-Medizintechnik GmbH410-144-1002024-06-28
04049197317276RZ Medizintechnik GmbHRZ-Medizintechnik GmbH420-587-1772024-06-28
00888515155862BOSS InstrumentsBOSS INSTRUMENTS, LTD., INC.70-38522024-02-28
00190776377762MillenniumAvalign Technologies, Inc.1-5345802023-09-08
B7682442010Buxton BioMedicalBuxton Biomedical Inc24-42012023-06-09
00840314227232gSourceGSOURCE LLCgS 52.01002020-01-08
08057968713543BLADES SUPPORT HANDLEHPF SRLH00503000992022-09-08
08057968713550BLADES SUPPORT HANDLE (KNURLED)HPF SRLH00503001992022-09-08
08057968713581CIRCULAR OSTEOTOMEHPF SRLH00500500992022-09-08
08057968713598OSTEOTOME - ADAPTER CONE #+2HPF SRLH00500510922022-09-08
08057968713604OSTEOTOME - ADAPTER CONE #+1HPF SRLH00500510912022-09-08
08057968713611OSTEOTOME - ADAPTER CONE #0HPF SRLH00500510992022-09-08
08057968713628OSTEOTOME - ADAPTER CONE #-2HPF SRLH00500510942022-09-08
08057968713635OSTEOTOME - ADAPTER CONE #-1HPF SRLH00500510932022-09-08
08057968718975BLADES SUPPORT HANDLE (KNURLED )HPF SRL01.10.10.20542022-09-08
08057968713536ACETABULAR OSTEOTOMEHPF SRLH00500501992022-09-01
00814639025033SHARDAPPLIED DENTAL, INC.A600-MBH 2022-05-20
00814639025682SHARDAPPLIED DENTAL, INC.A600-M6-BH2022-05-20
03662663022668ROI-ALDR Spine Usa, Inc.IR92002R2017-03-23
03662663022675ROI-ALDR Spine Usa, Inc.IR92003R2017-03-23
03662663022682ROI-ALDR Spine Usa, Inc.IR92004R2017-03-23
03662663022705Avenue LLDR Spine Usa, Inc.IR90511R2017-03-22
03662663022712Avenue LLDR Spine Usa, Inc.IR90512R2017-03-22
03662663022729Avenue LLDR Spine Usa, Inc.IR90513R2017-03-22
03662663022736Avenue LLDR Spine Usa, Inc.IR90505R-S2017-03-24
00190776163327MillenniumAvalign Technologies, Inc.1-08084012112021-11-01
00190776163334MillenniumAvalign Technologies, Inc.1-08084019112021-11-01
00190776163341MillenniumAvalign Technologies, Inc.1-210100012021-11-01
00190776163358MillenniumAvalign Technologies, Inc.1-2501492021-11-01
00190776163365MillenniumAvalign Technologies, Inc.10-410305SP2021-11-01
00840085201820SIRIONAstura MedicalGZA1000102021-07-16
00840085201837SIRIONAstura MedicalGZA1000202021-07-16
08800053007498BMS ChiselDENTIS CO. ,LTDDSCL-052021-06-02
08800053007504Bone Ridge Chisel(Angle)DENTIS CO. ,LTDDBCA152021-06-02
08800053007511Bone Ridge Chisel(Angle)DENTIS CO. ,LTDDBCA252021-06-02
00889024595958EXPLANT HANDLEZimmer, Inc.SSI0059332020-12-03
00889024595965EXPLANT HANDLEZimmer, Inc.SSI0059342020-12-03
00889024595972EXPLANT HANDLEZimmer, Inc.SSI0059352020-12-03
B58203012850N/AGEORGE TIEMANN & CO.B582030128502020-09-24
04046964686771AESCULAPAESCULAP, INC.MG046R2020-08-25
04046964686788AESCULAPAESCULAP, INC.MG047R2020-08-25
04046964686795AESCULAPAESCULAP, INC.MG048R2020-08-25
04046964686801AESCULAPAESCULAP, INC.MG049R2020-08-25
07540194010667Dr.Paleys Osteotomy SystemOrthopediatrics Canada ULCDRPOL-7002020-08-12
04046964676604AESCULAPAESCULAP, INC.MF137R2020-05-07
04038653176908AESCULAPAesculap AGOG201R2020-04-22
04061644033218Reicodentdevemed GmbH02-2811-002020-04-16
04061644020157devemeddevemed GmbH2811-002020-04-15
00857235006037Varian HalcyonVARIAN MEDICAL SYSTEMS, INC.3.02020-02-14
00857235006044Varian Ethos Radiotherapy SystemVARIAN MEDICAL SYSTEMS, INC.3.02020-02-14
M75552010002gSourceGSOURCE LLCgS 52.01002020-01-08
00840916135096ZEUS-CSPINAL ELEMENTS10112-42019-10-16
00880304836679Spinal SystemBIOMET SPINE LLC131M11062018-09-25
00880304836686Spinal SystemBIOMET SPINE LLC131M11072018-09-25
00880304836693Spinal SystemBIOMET SPINE LLC131M11082018-07-13
00880304836709Spinal SystemBIOMET SPINE LLC131M11092018-09-25
00880304836716Spinal SystemBIOMET SPINE LLC131M11102018-09-25
00880304836723Spinal SystemBIOMET SPINE LLC131M11112018-09-25
00880304836730Spinal SystemBIOMET SPINE LLC131M11122018-07-13
00880304836747Spinal SystemBIOMET SPINE LLC131M11132018-09-25