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
8,913
Last updated
2026-11-01 02:55:43

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00840606186506LateralSPINAL ELEMENTS, INC.81077-0082026-10-22
00840606186513LateralSPINAL ELEMENTS, INC.81077-0102026-10-22
00190776435592MillenniumAvalign Technologies, Inc.1-6020222026-10-20
B0842003500000Keos Lumbar InstrumentKEOSOsteotome, Straight, 7mm2023-02-10
00198506095870ELMED INCORPORATEDELMED INCORPORATEDST33694-012026-10-09
00840277133915Innomed, Inc.INNOMED, INC.S60002026-10-09
B7687715080Buxton Biomedical, IncBUXTON BIOMEDICAL, INC.77-15082026-10-06
00190776432935MillenniumAvalign Technologies, Inc.1-01183722026-09-30
00840329838676BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.B640372026-09-30
00840329838683BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.B640402026-09-30
00190776432812MillenniumAvalign Technologies, Inc.1-4103162026-09-29
00815432029068MotoBANDCROSSROADS EXTREMITY SYSTEMSGraterBladeTM - Stryker Connection2021-01-06
00815432029075MotoBANDCROSSROADS EXTREMITY SYSTEMSGraterBladeTM - Connmed/Hall Connection2021-01-06
B382SD914455070Surgical DirectSurgical Direct, Inc.SD914455072026-09-29
00190776432713MillenniumAvalign Technologies, Inc.1-2422460002026-09-28
00190776432720MillenniumAvalign Technologies, Inc.1-2422420002026-09-28
00190776432737MillenniumAvalign Technologies, Inc.1-2422750002026-09-28
00810130207541MSIModern Surgical Instruments LLC49-03522026-09-24
00810130207558MSIModern Surgical Instruments LLC49-03512026-09-24
07392532070303Astra Tech Implant System®Dentsply Implants Manufacturing GmbH243392023-10-19
07392532070310Astra Tech Implant System®Dentsply Implants Manufacturing GmbH246842023-10-19
07392532070327Astra Tech Implant System®Dentsply Implants Manufacturing GmbH246852023-10-19
07392532070334Astra Tech Implant System®Dentsply Implants Manufacturing GmbH246862023-10-19
07392532070341Astra Tech Implant System®Dentsply Implants Manufacturing GmbH246872023-10-19
07392532070358Astra Tech Implant System®Dentsply Implants Manufacturing GmbH246882023-10-19
07392532070365Astra Tech Implant System®Dentsply Implants Manufacturing GmbH246892023-10-19
07392532070372Astra Tech Implant System®Dentsply Implants Manufacturing GmbH246902023-10-19
07392532070389Astra Tech Implant System®Dentsply Implants Manufacturing GmbH246912023-10-19
07392532070396Astra Tech Implant System®Dentsply Implants Manufacturing GmbH246922023-10-19
B7682443150Buxton BiomedicalBUXTON BIOMEDICAL, INC.24-43152023-05-19
B7685671020Buxton BioMedicalBUXTON BIOMEDICAL, INC.56-71022022-12-22
B7685671030Buxton BioMedicalBUXTON BIOMEDICAL, INC.56-71032022-12-22
B7685671040Buxton BioMedicalBUXTON BIOMEDICAL, INC.56-71042022-12-22
B7685671060Buxton BioMedicalBUXTON BIOMEDICAL, INC.56-71062022-12-22
B7685671080Buxton BioMedicalBUXTON BIOMEDICAL, INC.56-71082022-12-22
B7685671100Buxton BioMedicalBUXTON BIOMEDICAL, INC.56-71102022-12-22
B7685671120Buxton BioMedicalBUXTON BIOMEDICAL, INC.56-71122022-12-22
B7685671150Buxton BioMedicalBUXTON BIOMEDICAL, INC.56-71152022-12-22
B7685671240Buxton BioMedicalBUXTON BIOMEDICAL, INC.56-71242025-09-24
B7685671280Buxton BioMedicalBUXTON BIOMEDICAL, INC.56-71282025-12-12
B7685671300Buxton BioMedicalBUXTON BIOMEDICAL, INC.56-71302023-10-20
B7685671320Buxton BioMedicalBUXTON BIOMEDICAL, INC.56-71322023-10-20
B7685671950Buxton BioMedicalBUXTON BIOMEDICAL, INC.56-71952024-05-31
B7685672040Buxton BioMedicalBUXTON BIOMEDICAL, INC.56-72042023-10-20
B7685672060Buxton BioMedicalBUXTON BIOMEDICAL, INC.56-72062024-10-31
B7685672080Buxton BioMedicalBUXTON BIOMEDICAL, INC.56-72082023-10-20
B7685672100Buxton BioMedicalBUXTON BIOMEDICAL, INC.56-72102024-06-05
B7685673060Buxton BioMedicalBUXTON BIOMEDICAL, INC.56-73062023-10-20
B7685673080Buxton BioMedicalBUXTON BIOMEDICAL, INC.56-73082023-10-20
B7685673100Buxton BioMedicalBUXTON BIOMEDICAL, INC.56-73102024-04-17
B7685673120Buxton BioMedicalBUXTON BIOMEDICAL, INC.56-73122024-10-31
B7685673150Buxton BioMedicalBUXTON BIOMEDICAL, INC.56-73152024-10-31
B7687711040Buxton BioMedicalBUXTON BIOMEDICAL, INC.77-11042024-04-17
B7687711050Buxton BioMedicalBUXTON BIOMEDICAL, INC.77-11052024-06-21
B7687711060Buxton BioMedicalBUXTON BIOMEDICAL, INC.77-11062023-10-27
B7687711080Buxton BioMedicalBUXTON BIOMEDICAL, INC.77-11082023-01-27
B7687711100Buxton BioMedicalBUXTON BIOMEDICAL, INC.77-11102023-01-27
B7687711120Buxton BiomedicalBUXTON BIOMEDICAL, INC.77-11122023-12-08
B7687711150Buxton BioMedicalBUXTON BIOMEDICAL, INC.77-11152023-10-20
B7687711200Buxton BioMedicalBUXTON BIOMEDICAL, INC.77-11202024-08-28
B7687711220Buxton BioMedicalBUXTON BIOMEDICAL, INC.77-11222023-02-21
B7687711250Buxton BioMedicalBUXTON BIOMEDICAL, INC.77-11252023-08-09
B7687715040Buxton BioMedicalBUXTON BIOMEDICAL, INC.77-15042025-11-03
B7687715100Buxton BioMedicalBUXTON BIOMEDICAL, INC.77-15102025-01-10
B7687715120Buxton BioMedicalBUXTON BIOMEDICAL, INC.77-15122025-11-03
B7687715150Buxton BioMedicalBUXTON BIOMEDICAL, INC.77-15152023-04-10
B7687715200Buxton BioMedicalBUXTON BIOMEDICAL, INC.77-15202024-09-06
B76877152000Buxton BioMedicalBUXTON BIOMEDICAL, INC.77-11202024-06-05
B7687715220Buxton BioMedicalBUXTON BIOMEDICAL, INC.77-15222023-04-10
B7687715250Buxton BioMedicalBUXTON BIOMEDICAL, INC.77-15252024-06-06
B7687740070Buxton BioMedicalBUXTON BIOMEDICAL, INC.77-40072024-06-07
B7687740150Buxton BioMedicalBUXTON BIOMEDICAL, INC.77-40152023-11-03
B7687740250Buxton BioMedicalBUXTON BIOMEDICAL, INC.77-40252024-10-15
B7687740300Buxton BioMedicalBUXTON BIOMEDICAL, INC.77-40302023-08-09
B7687771080Buxton BioMedicalBUXTON BIOMEDICAL, INC.77-71082025-11-13
B7687771100Buxton BioMedicalBUXTON BIOMEDICAL, INC.77-71102025-11-13
B7687771130Buxton BioMedicalBUXTON BIOMEDICAL, INC.77-71132025-11-21
B7687771150Buxton BioMedicalBUXTON BIOMEDICAL, INC.77-71152025-11-21
B7687771180Buxton BioMedicalBUXTON BIOMEDICAL, INC.77-71182025-11-13
B7687771200Buxton BioMedicalBUXTON BIOMEDICAL, INC.77-71202025-11-21