FDA.reportPublic FDA data

Buxton Biomedical, Inc

Primary DI
B7687715080
Brand
Buxton Biomedical, Inc
Company
BUXTON BIOMEDICAL, INC.
Model
77-1508
Catalog number
77-1508
Device description
Dahmen Osteotome, angled, 8 mm
Published
2026-10-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

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
B7687715080PrimaryHIBCC0

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
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B7685216080Buxton Biomedical, Inc52-160852-16082026-10-06
B7687419600Buxton Biomedical, Inc74-196074-19602026-10-06
B7688399130Buxton Biomedical, Inc83-991383-99132026-10-06
B7688452230Buxton Biomedical, Inc84-522384-52232026-10-06
B7688452240Buxton Biomedical, Inc84-522484-52242026-10-06
B76884751630Buxton Biomedical, Inc847-5163847-51632026-10-06
B7688632520Buxton Biomedical, Inc86-325286-32522026-10-06
B7688652520Buxton Biomedical, Inc86-525286-52522026-10-06
B76886844120Buxton Biomedical, Inc868-4412868-44122026-10-06
B7683361430Buxton BioMedical33-614333-61432026-06-19
B7683363220Buxton BioMedical33-632233-63222026-06-19
B7685215250Buxton BioMedical52-152552-15252026-06-19
B7685231210Buxton BioMedical52-312152-31212026-06-19
B7685490130Buxton BioMedical54-901354-90132026-06-19
B7687417030Buxton BioMedical74-170374-17032026-06-19
B7685252430Buxton BioMedical52-524352-52432026-06-05
B76884850220Buxton BioMedical848-5022848-50222026-06-05
B7688532051620Buxton BioMedical853-20-5162853-20-51622026-06-05
B7688532051630Buxton BioMedical853-20-5163853-20-51632026-06-05
B7688532051720Buxton BioMedical853-20-5172853-20-51722026-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776432935MillenniumAvalign Technologies, Inc.HWM2026-09-30
00840329838676BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.HWM2026-09-30
00840329838683BLACK & BLACK SURGICAL, INC.BLACK & BLACK SURGICAL, INC.HWM2026-09-30
G14164746930Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-09-30
G141647481020Carnegie Surgical LLCCarnegie Surgical LLCHWM2026-09-30
00190776432812MillenniumAvalign Technologies, Inc.HWM2026-09-29
00190776432713MillenniumAvalign Technologies, Inc.HWM2026-09-28
00190776432720MillenniumAvalign Technologies, Inc.HWM2026-09-28
00190776432737MillenniumAvalign Technologies, Inc.HWM2026-09-28
00190776431570MillenniumAvalign Technologies, Inc.HWM2026-09-22
00190776431037MillenniumAvalign Technologies, Inc.HWM2026-09-21
00190776431044MillenniumAvalign Technologies, Inc.HWM2026-09-21
00190776431051MillenniumAvalign Technologies, Inc.HWM2026-09-21
00190776431020MillenniumAvalign Technologies, Inc.HWM2026-09-18
00190776429089MillenniumAvalign Technologies, Inc.HWM2026-09-04
00190776429096MillenniumAvalign Technologies, Inc.HWM2026-09-04
00810111227360OsteotomeTreace Medical Concepts, Inc.HWM2026-08-25
00190776425807MillenniumAvalign Technologies, Inc.HWM2026-08-17
10705034579887N/AMedos International SàrlHWM2026-08-14
10705034579894N/AMedos International SàrlHWM2026-08-14
00190776424459MillenniumAvalign Technologies, Inc.HWM2026-08-07
00190776424466MillenniumAvalign Technologies, Inc.HWM2026-08-07
00190776424473MillenniumAvalign Technologies, Inc.HWM2026-08-07
00190776422738MillenniumAvalign Technologies, Inc.HWM2026-08-03
07640221373663SCALASpineArt SAHWM2026-07-24
07640221373670SCALASpineArt SAHWM2026-07-24
00190776421861MillenniumAvalign Technologies, Inc.HWM2026-07-23
00190776400422MillenniumAvalign Technologies, Inc.HWM2026-07-17
00190776400439MillenniumAvalign Technologies, Inc.HWM2026-07-17
B756SBLDFLAT17010Shukla Blade S9BLADEShukla MedicalHWM2026-07-09