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
8,899
Last updated
2026-10-04 01:48:21

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
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
B7687771250Buxton BioMedicalBUXTON BIOMEDICAL, INC.77-71252025-11-21
B7687771300Buxton BioMedicalBUXTON BIOMEDICAL, INC.77-71302025-11-21
00190776400231MillenniumAvalign Technologies, Inc.85-780023782026-07-16
00190776431570MillenniumAvalign Technologies, Inc.1-750105802026-09-22
07613327263381RELIANCE LITeStryker Corporation480605002019-10-14
07613327268362RELIANCEStryker Corporation483602002018-09-24
07613327268379RELIANCEStryker Corporation483602102018-09-24
07613327269987RELIANCE ALStryker Corporation483662122018-09-24
07613327366389Posterior TLIFStryker Corporation6802205052019-09-12
07613327366631Posterior TLIFStryker Corporation6802205042019-09-12
10888857112742MESA Spinal SystemVB Spine LLC5601-900062022-09-23
10888857118140ALEUTIAN Interbody SystemsVB Spine LLC602-905082022-08-05
10888857118157ALEUTIAN Interbody SystemsVB Spine LLC602-905092022-08-05
10888857118164ALEUTIAN Interbody SystemsVB Spine LLC602-905102022-08-05
10888857550315K2M General InstrumentsVB Spine LLCPRO-1112-012022-02-15
10888857550322K2M General InstrumentsVB Spine LLCPRO-1112-022022-02-15
10888857550339K2M General InstrumentsVB Spine LLCPRO-1112-032022-02-15