FDA.reportPublic FDA data

BoneFoam

Primary DI
00810075280784
Brand
BoneFoam
Company
BONE FOAM, INC.
Model
104.NPS
Catalog number
104.NPS
Device description
Nextend System
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
KQZCOMPONENT, TRACTION, NON-INVASIVE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CCXSupport, Patient PositionAnesthesiology1
KQZComponent, Traction, Non-InvasiveOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810075280784PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810075280784008100752807848100752807840810075280784

GMDN Terms#

Term, Definition table
TermDefinition
Horizontal non-powered traction systemAn assembly of devices designed to be attached to a table for the application of constant horizontal traction forces to the cervical or lumbar vertebrae by means of attached harnesses whilst the patient typically lies in a supine position on the table during treatment. The assembly usually consists of several specialized harnesses, a combination of pulleys and cords, and a set of weights that hang from the cords as the source of the traction force (the patient's own weight or pneumatic devices may also be used). Adjustable spreader bars may be used to vary the angle at which the cord applies the traction. The assembly is used in orthopaedic and/or physical therapy procedures.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079636174
Device count
1
Premarket exempt
true
Kit
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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10197344149834MEDLINEMEDLINE INDUSTRIES, INC.CCX2025-09-22
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