FDA.reportPublic FDA data

BoneFoam

Primary DI
00810075280814
Brand
BoneFoam
Company
BONE FOAM, INC.
Model
104.NPS-TA
Catalog number
104.NPS-TA
Device description
Nextend Traction Anchor
Published
2022-05-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
CCXSupport, Patient Position
HSTApparatus, traction, non-powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1
HSTApparatus, Traction, Non-PoweredOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810075280814PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810075280814008100752808148100752808140810075280814

GMDN Terms#

Term, Definition table
TermDefinition
Bed traction frameAn adjustable support structure usually attached to a patient's bed and designed for management of various orthopaedic conditions. It typically consists of a steel tubing structure that includes brackets and/or pulleys; it includes a post for the headboard and/or footboard, and often an adjustable-length top bar or rail with a hanging trapeze. The device is designed for use in combination with weights and/or other attachments to produce the desired traction in patients while permitting some freedom of motion. It is used to treat patients with fractures and other orthopaedic disorders (e.g., of the lower or cervical spine, hip).

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079636174
Device count
1
Premarket exempt
true
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810075281521BoneFoam104.NPL-SUK-BX5104.NPL-SUK-BX52025-08-15
00810075281606BoneFoam925.SG-BX10925.SG-BX102025-08-15
00810075281620BoneFoam925.ZDK-DOC-BX12925.ZDK-DOC-BX122025-08-15
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
00810075281613BoneFoam925.ZDK-DOC-BX12925.ZDK-DOC-BX122025-08-15
00810075280005BoneFoam10-910-0010-910-002022-05-22
00810075280036BoneFoam10-910-02-C10-910-02-C2022-05-22
00810075280043BoneFoam10-910-0210-910-022022-05-22
00810075280050BoneFoam10-910-07-C10-910-07-C2022-05-22
00810075280524BoneFoam925.PROP-R-BX5925.PROP-R-BX52022-05-22
00810075280531BoneFoam925.PROP-L-BX5925.PROP-L-BX52022-05-22
00810075280593BoneFoam925.PF-SSP-BX6925.PF-SSP-BX62022-05-22
00810075280616BoneFoam925.ZDK-BX12925.ZDK-BX122022-05-22
00810075280623BoneFoam925.ZDK-AveraMarshall-BX12925.ZDK-AveraMarshall-BX122022-05-22
00810075280630BoneFoam925.ZDK-AveraMcKennan-BX12925.ZDK-AveraMcKennan-BX122022-05-22
00810075280647BoneFoam925.ZDK-Mansfield-BX12925.ZDK-Mansfield-BX122022-05-22

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Primary DI, Brand, Company table
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07613327672718Sage Multi-Position MATS 2.0SAGE PRODUCTS, LLCCCX2025-11-19
10197344149834MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-22
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