FDA.reportPublic FDA data

Buxton BioMedical

Primary DI
B7687715100
Brand
Buxton BioMedical
Company
Buxton Biomedical Inc
Model
77-1510
Catalog number
77-1510
Device description
Dahmen Osteotome, angled, 10mm
Published
2025-01-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
HWMOsteotome

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWMOsteotomeGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B7687715100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic osteotomeA 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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
808385207
Device count
1
Premarket exempt
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B7681901210Buxton BioMedical190-121190-1212023-07-07
B7683439140Buxton BioMedical34-391434-39142026-04-24
B7685674460Buxton BioMedical56-744656-74462026-04-24
B7685676080Buxton BioMedical56-760856-76082026-04-24
B7685677060Buxton BioMedical56-770656-77062026-04-24
B7682462200Buxton BioMedical24-622024-62202026-04-23
B7683434130Buxton BioMedical34-341334-34132026-04-23
B7687417000Buxton BioMedical74-170074-17002026-04-23
B7687684070Buxton BioMedical76-840776-84072026-04-23
B7688386020Buxton BioMedical83-860283-86022026-04-23
B7688441030Buxton BioMedical84-410384-41032026-04-23
B76884751040Buxton BioMedical847-5104847-51042026-04-23
B76884754320Buxton BioMedical847-5432847-54322026-04-23
B7688532061030Buxton BioMedical853-20-6103853-20-61032026-04-23
B7688532351120Buxton BioMedical853-23-5112853-23-51122026-04-23
B7688532351130Buxton BioMedical853-23-5113853-23-51132026-04-23
B7688650540Buxton BioMedical86-505486-50542026-04-23
B7688441020Buxton BioMedical84-410284-41022025-12-31
B7688457751630Buxton BioMedical845-77-5163845-77-51632025-12-31
B76885362280Buxton BioMedical853-6228853-62282025-12-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
09348811099624INKAThe Trustee for KAISER FAMILY TRUSTHWM2026-03-18
09348811110442INKAThe Trustee for KAISER FAMILY TRUSTHWM2026-03-18
09348811111289INKAThe Trustee for KAISER FAMILY TRUSTHWM2026-03-18
10381780503316Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
10381780503323Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
10381780503330Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
10381780503347Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
10381780503354Integra® Miltex®INTEGRA LIFESCIENCES PRODUCTION CORPORATIONHWM2020-10-01
10603295080770NADEPUY (IRELAND)HWM2018-09-24
10603295080787NADEPUY (IRELAND)HWM2018-09-24
10603295080794NADEPUY (IRELAND)HWM2018-09-24
10603295083160SIGMADEPUY (IRELAND)HWM2018-09-24
10603295083191SIGMADEPUY (IRELAND)HWM2018-09-24
10603295090403GLOBAL APDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295090410GLOBAL APDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295090427GLOBAL APDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295090434GLOBAL APDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295090441GLOBAL APDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295090458GLOBAL APDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295122739NADEPUY (IRELAND)HWM2018-09-24
10603295122746NADEPUY (IRELAND)HWM2018-09-24
10603295122753NADEPUY (IRELAND)HWM2018-09-24
10603295122760NADEPUY (IRELAND)HWM2018-09-24
10603295122777NADEPUY (IRELAND)HWM2018-09-24
10603295122784NADEPUY (IRELAND)HWM2018-09-24
10603295122791NADEPUY (IRELAND)HWM2018-09-24
10603295123071MORELANDDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295123088MORELANDDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295123095MORELANDDEPUY ORTHOPAEDICS, INC.HWM2018-09-24
10603295123101MORELANDDEPUY ORTHOPAEDICS, INC.HWM2018-09-24