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
8,865
Last updated
2026-07-17 22:01:40

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
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
00810111222488OsteotomeTreace Medical Concepts, Inc.02-000762024-01-08
00810111222495OsteotomeTreace Medical Concepts, Inc.02-000772024-01-08
00810111222518OsteotomeTreace Medical Concepts, Inc.02-000052024-01-08
00810130205226MSIModern Surgical Instruments LLC46-03102025-01-17
00810141040519Foundation Surgical InterwedgeFOUNDATION SURGICAL GROUP INCFS50-3400002025-10-24
00810158217577PRINCETONPrinceton Medical Group, Inc.33668-062025-10-08
00810158217768PRINCETONPrinceton Medical Group, Inc.49627-012025-10-17
00810158217904PRINCETONPrinceton Medical Group, Inc.33716-182025-11-03
00810158217911PRINCETONPrinceton Medical Group, Inc.41156-182025-11-03
00810158217959PRINCETONPrinceton Medical Group, Inc.33654-082025-11-03
00810158218017PRINCETONPrinceton Medical Group, Inc.33668-102025-11-03
00810158218024PRINCETONPrinceton Medical Group, Inc.33759-032025-11-03
00810158218031PRINCETONPrinceton Medical Group, Inc.33720-212025-11-03
00810158219793PRINCETONPrinceton Medical Group, Inc.33654-102026-05-20
00810158219816PRINCETONPrinceton Medical Group, Inc.47471-042026-05-20
00811801030437General InstrumentsALPHATEC SPINE, INC.CI-10530-1082020-09-19
00811801032653General InstrumentsALPHATEC SPINE, INC.CI-10530-2082020-09-19
00811801035555General InstrumentsALPHATEC SPINE, INC.CI-10203-082020-09-19
00811801036545General InstrumentsALPHATEC SPINE, INC.CI-10285-13-012020-09-19
00811801036552General InstrumentsALPHATEC SPINE, INC.CI-10285-25-012020-09-19
00811801036569General InstrumentsALPHATEC SPINE, INC.CI-10285-13-022020-09-19
00811801036576General InstrumentsALPHATEC SPINE, INC.CI-10285-25-022020-09-19
00811801036873General InstrumentsALPHATEC SPINE, INC.CI-10285-13-102020-09-19
00811801036880General InstrumentsALPHATEC SPINE, INC.CI-10285-18-102020-09-19
00811801036897General InstrumentsALPHATEC SPINE, INC.CI-10285-25-102020-09-19
00811801036903General InstrumentsALPHATEC SPINE, INC.CI-10285-13-202020-09-19
00811801036910General InstrumentsALPHATEC SPINE, INC.CI-10285-18-202020-09-19
008129980401244WEB Medical4web MedicalLSTS-0006022020-11-05
008129980401314WEB Medical4web MedicalLSTS-0006032020-11-05
008129980401484WEB Medical4web MedicalLSTS-0006042020-11-05