FDA.reportPublic FDA data

Buxton BioMedical

Primary DI
B7685612550
Brand
Buxton BioMedical
Company
BUXTON BIOMEDICAL, INC.
Model
56-1255
Catalog number
56-1255
Device description
Distractor, w/dual pin guides
Published
2025-07-23
Public version status
Update
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
GADRetractor

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GADRetractorGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B7685612550PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone distraction forcepsA hand-held, manual, open-surgery instrument with sturdy handles and blade-like jaws designed to distract (force apart) two bone surfaces to enable a surgical procedure, e.g., two vertebrae during a spinal surgical intervention. It has a scissors-like lever action with straight or curved handles and is typically made of high-grade stainless steel. It is available in various sizes with the distraction blades at the working end which are activated through a single or double-jointed pivot that transfers the necessary force to create distraction; the blades are typically short and slender to fit between bone segments or pre-implanted pedicle screws. 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
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
B7688654120Buxton BioMedical86-541286-54122026-06-05
B7684612300Buxton BioMedical46-123046-12302026-06-02
B7685410360Buxton BioMedical54-103654-10362026-06-02
B7685631130Buxton BioMedical56-311356-31132026-06-02
B7687425470Buxton BioMedical74-254774-25472026-06-02
B7687425570Buxton BioMedical74-255774-25572026-06-02
B7688371010Buxton BioMedical83-710183-71012026-06-02
B7688532051730Buxton BioMedical853-20-5173853-20-51732026-06-02
B7688532061040Buxton BioMedical853-20-6104853-20-61042026-06-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776432287MillenniumAvalign Technologies, Inc.GAD2026-09-24
00190776432294MillenniumAvalign Technologies, Inc.GAD2026-09-24
00190776432393MillenniumAvalign Technologies, Inc.GAD2026-09-24
00724995266912Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266943Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266950Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266967Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266974Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266981Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995266998Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267001Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267025Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267032Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
00724995267537Snowden-PencerSTERIS Deutschland GmbHGAD2026-09-24
B7683361430Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2026-06-19
B7683363220Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2026-06-19
B7683439140Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2026-04-24
B7682462200Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2026-04-23
B7682461610Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-12-12
B7685612810Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-12-12
B7685255060Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-11-03
B7685255120Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-11-03
B7685257350Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-11-03
B7685257670Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-11-03
B7685255190Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-09-24
B7685257320Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-09-24
B7685661130Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-06-13
B7682460140Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-05-30
B7683359530Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-05-30
B7685257880Buxton BioMedicalBUXTON BIOMEDICAL, INC.GAD2025-05-20