FDA.reportPublic FDA data

Orthopaedic osteotome

Definition
A chisel-like, one-piece manual surgical instrument designed to cut and/or shape bone by percussion during an orthopaedic procedure. It is hand-held by the operator who uses a surgical mallet or hammer to manually impart a force to the proximal end of the instrument. The distal end (the cutting or shaping edge) is sharp, often flat, but can be curved (concave) in design, and is typically bevelled on both sides with sloping curves. It is either entirely made of metal (e.g., high-grade stainless steel) or has a metal blade with a handle made of synthetic material (e.g., Tufnol). This is a reusable device.
GUDID devices
8,871
Last updated
2026-08-08 10:09:31

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00841435123717TecometTECOMET INC.464872026-07-30
00841435123724TecometTECOMET INC.464882026-07-30
00841435123731TecometTECOMET INC.464902026-07-30
00198506093821ELMED INCORPORATEDELMED INCORPORATEDST230819C2026-07-29
04059453095022Hermann Medizintechnik GmbHHermann Medizintechnik GmbHH132-635092026-07-27
B382SD914455280Surgical DirectSurgical Direct, Inc.SD914455282026-07-27
B382SD914457090Surgical DirectSurgical Direct, Inc.SD914457092026-07-27
B382SD914457260Surgical DirectSurgical Direct, Inc.SD914457262026-07-27
B382SD914458100Surgical DirectSurgical Direct, Inc.SD914458102026-07-27
B382SD9144781000Surgical DirectSurgical Direct, Inc.SD9144781002026-07-27
B382SD9144781010Surgical DirectSurgical Direct, Inc.SD9144781012026-07-27
04038653148998AESCULAPAesculap AGDO706R2020-04-21
07640221373663SCALASpineArt SASLA-IN 01 01-N2026-07-24
07640221373670SCALASpineArt SASLA-IN 01 02-N2026-07-24
00190776421861MillenniumAvalign Technologies, Inc.1-751102502026-07-23
00841435121355TecometTECOMET INC.2399-16-0002023-07-21
00841435123557TecometTECOMET INC.463592025-02-07
00841435123564TecometTECOMET INC.463612025-02-07
00841435123571TecometTECOMET INC.463632025-02-07
00198506092053ELMED INCORPORATEDELMED INCORPORATEDST2330512026-07-22
00198506092060ELMED INCORPORATEDELMED INCORPORATEDST2330522026-07-22
00198506092077ELMED INCORPORATEDELMED INCORPORATEDST2330532026-07-22
00198506092084ELMED INCORPORATEDELMED INCORPORATEDST2330542026-07-22
00198506092091ELMED INCORPORATEDELMED INCORPORATEDST2330552026-07-22
00810135960649EARP INSTRUMENTSNVision Biomedical Technologies, Inc.EARP-O2023-10-18
00198506092107ELMED INCORPORATEDELMED INCORPORATEDST2330612026-07-17
00198506092114ELMED INCORPORATEDELMED INCORPORATEDST2330642026-07-17
00198506092121ELMED INCORPORATEDELMED INCORPORATEDST2330652026-07-17
04059453127891Hermann Medizintechnik GmbHHermann Medizintechnik GmbHH146-471072026-07-16
00190776395384MillenniumAvalign Technologies, Inc.85-580023972026-07-13
10705034647470CROSSNAV CONDUITMedos International Sàrl3010-21-3012026-07-09
10705034647487CROSSNAV CONDUITMedos International Sàrl3010-21-3032026-07-09
00810143904666SURGIPROSSurgipros, LLC80-1100SP2026-06-01
00810143904673SURGIPROSSurgipros, LLC80-1102SP2026-06-01
00810143907261SURGIPROSSurgipros, LLCFL101SP2026-06-01
00810143907278SURGIPROSSurgipros, LLCFL102SP2026-06-01
00810143907308SURGIPROSSurgipros, LLCFL108SP2026-06-01
00810143907315SURGIPROSSurgipros, LLCFL109SP2026-06-01
00810212930008SURGIPROSSurgipros, LLCOS-1/4SP2026-06-01
00810212930015SURGIPROSSurgipros, LLCOS-3/8SP2026-06-01
00810212930022SURGIPROSSurgipros, LLCOS-1/2SP2026-06-01
00810212930039SURGIPROSSurgipros, LLCOS-5/8SP2026-06-01
00810212930046SURGIPROSSurgipros, LLCOS-3/4SP2026-06-01
00810212930053SURGIPROSSurgipros, LLCOS-1SP2026-06-01
00810212930060SURGIPROSSurgipros, LLCOS-C1/4SP2026-06-01
00810212930077SURGIPROSSurgipros, LLCOS-C3/8SP2026-06-01
00810212930084SURGIPROSSurgipros, LLCOS-C1/2SP2026-06-01
00810212930091SURGIPROSSurgipros, LLCOS-C5/8SP2026-06-01
00810212930107SURGIPROSSurgipros, LLCOS-C3/4SP2026-06-01
00810212930114SURGIPROSSurgipros, LLCOS-C1SP2026-06-01
00190776399047MillenniumAvalign Technologies, Inc.1-3700032025-05-27
00190776413453MillenniumAvalign Technologies, Inc.1-25022025-10-09
00190776413491MillenniumAvalign Technologies, Inc.1-2421030002025-10-09
00190776414054MillenniumAvalign Technologies, Inc.1-534500-92025-10-21
00190776414061MillenniumAvalign Technologies, Inc.1-534510-92025-10-21
00190776414078MillenniumAvalign Technologies, Inc.1-534520-92025-10-21
00190776414085MillenniumAvalign Technologies, Inc.1-534530-92025-10-21
00190776414092MillenniumAvalign Technologies, Inc.1-534540-92025-10-21
00190776414108MillenniumAvalign Technologies, Inc.1-534550-92025-10-21
00190776414115MillenniumAvalign Technologies, Inc.1-534560-92025-10-21
00190776414122MillenniumAvalign Technologies, Inc.1-534570-92025-10-21
00190776414139MillenniumAvalign Technologies, Inc.1-534580-92025-10-21
00190776414146MillenniumAvalign Technologies, Inc.1-534590-92025-10-21
00190776414153MillenniumAvalign Technologies, Inc.1-534600-92025-10-21
00190776414160MillenniumAvalign Technologies, Inc.1-534610-92025-10-21
00190776414177MillenniumAvalign Technologies, Inc.1-534620-92025-10-21
00190776414184MillenniumAvalign Technologies, Inc.1-534630-92025-10-21
00190776419813MillenniumAvalign Technologies, Inc.1-016746-52026-04-15
00190776420505MillenniumAvalign Technologies, Inc.1-0282422026-04-16
00190776421373MillenniumAvalign Technologies, Inc.1-0104202026-05-05
00190776421519MillenniumAvalign Technologies, Inc.1-2501682026-05-05
00192896105461Stille Type OsteotomeSONTEC INSTRUMENTS, INC.330-7342020-11-16
00192896105492Obwegeser Split OsteotomeSONTEC INSTRUMENTS, INC.330-1302020-11-16
00196449034543Anatomic Access LLIFTyber Medical, LLC812900002025-10-22
00198506086281ELMED INCORPORATEDELMED INCORPORATEDSTSM230919JC2025-10-22
00198506086298ELMED INCORPORATEDELMED INCORPORATEDSTSM230906JC2025-10-22
00198506086304ELMED INCORPORATEDELMED INCORPORATEDSTSM230932JC2025-10-22
00198506086465ELMED INCORPORATEDELMED INCORPORATED23-0819C2025-11-05
00199150069705Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.EX12250022026-03-28
00199150070657Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.EX01260062026-04-06