FDA.reportPublic FDA data

BoneFoam

Primary DI
00810075281620
Brand
BoneFoam
Company
BONE FOAM, INC.
Model
925.ZDK-DOC-BX12
Catalog number
925.ZDK-DOC-BX12
Device description
Zero Degree Knee DOC Box of 12
Published
2025-08-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
IQIORTHOSIS, LIMB BRACE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IQIOrthosis, Limb BracePhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810075281620PrimaryGS10
00810075281613Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810075281620008100752816208100752816200810075281620
00810075281613008100752816138100752816130810075281613

GMDN Terms#

Term, Definition table
TermDefinition
Leg/knee cushionA soft pillow or pad intended to be placed under or between the leg(s)/knee(s) of a patient during the treatment/prevention of musculoskeletal and/or circulatory disorders. It is primarily intended for support when the patient is lying down, and may be used for one or more of the following: to reduce pressure on or between the legs, to improve postural alignment (e.g., of the spine or legs), to improve blood circulation in the lower extremities, and/or to prevent pressure sores/ulcers.

Regulatory Flags#

DUNS number
079636174
Device count
12
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810075281675BoneFoam104.UPC-SUK-BX5104.UPC-SUK-BX52026-07-28
00810075281668BoneFoam104.NPC-SUK-BX5104.NPC-SUK-BX52026-06-12
00810075280005BoneFoam10-910-0010-910-002022-05-22
00810075280067BoneFoam10-910-0310-910-032022-05-22
00810075281316BoneFoam925.UPS-DBC-BX20925.UPS-DBC-BX202022-12-19
00810075281279BoneFoam925.UPS-R-UB925.UPS-R-UB2022-11-21
00810075281286BoneFoam925.UPS-R-LB925.UPS-R-LB2022-11-21
00810075281293BoneFoam925.UPS-S-UB925.UPS-S-UB2022-11-21
00810075281309BoneFoam925.UPS-S-LB925.UPS-S-LB2022-11-21
00810075281347BoneFoam925.UPS-R925.UPS-R2022-11-21
00810075281354BoneFoam925.UPS-S925.UPS-S2022-11-21
00810075280074BoneFoam10-910-06-C10-910-06-C2022-05-22
00810075280081BoneFoam10-910-01-C10-910-01-C2022-05-22
00810075281521BoneFoam104.NPL-SUK-BX5104.NPL-SUK-BX52025-08-15
00810075281606BoneFoam925.SG-BX10925.SG-BX102025-08-15
00810075281491BoneFoam104.NPL104.NPL2025-08-15
00810075281507BoneFoam104.NPLB104.NPLB2025-08-15
00810075281514BoneFoam104.NPL-SUK-BX5104.NPL-SUK-BX52025-08-15
00810075281538BoneFoam104.NPSB104.NPSB2025-08-15
00810075281590BoneFoam925.SG-BX10925.SG-BX102025-08-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00636257220733MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220740MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220757MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220764MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220771MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220788MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220795MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220801MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220887MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220894MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220900MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220917MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220924MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220931MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220948MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220955MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220962MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220979MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220986MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257220993MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257221006MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257221068MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257221075MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00636257221082MEDIMEDI MANUFACTURING, INC.IQI2026-10-12
00840536824288PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824295PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824301PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824318PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824325PediHipORTHOPEDIATRICS CORP.IQI2026-10-07
00840536824332PediHipORTHOPEDIATRICS CORP.IQI2026-10-07