FDA.reportPublic FDA data

Accufuse Cervical System

Primary DI
00810016800002
Brand
Accufuse Cervical System
Company
ABSOLUTE ADVANTAGE MEDICAL, LLC
Model
1P7C5
Catalog number
1P7C5
Device description
Cervical Plate 1 Level 7mm
Published
2019-04-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810016800002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810016800002008100168000028100168000020810016800002

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small implantable sheet of solid material that is attached to the spine with screws for spinal immobilization and is made of a material that is not chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities (e.g., during anterior/posterior cervical, anterior/posterior lumbar, thoracolumbar, and occipital fixation procedures).

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
056248579
Device count
1
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810016801078Accufuse Cervical System10-1310-132019-04-24
00810016800019Accufuse Cervical System1P9C71P9C72019-04-24
00810016800026Accufuse Cervical System1P8C61P8C62019-04-24
00810016800033Accufuse Cervical System1P10C81P10C82019-04-24
00810016800040Accufuse Cervical System1P11C91P11C92019-04-24
00810016800057Accufuse Cervical System1P12C101P12C102019-04-24
00810016800064Accufuse Cervical System1P13C111P13C112019-04-24
00810016800071Accufuse Cervical System1P14C121P14C122019-04-24
00810016800088Accufuse Cervical System2P232P232019-04-24
00810016800095Accufuse Cervical System2P262P262019-04-24
00810016800101Accufuse Cervical System2P292P292019-04-24
00810016800118Accufuse Cervical System2P322P322019-04-24
00810016800125Accufuse Cervical System2P352P352019-04-24
00810016800132Accufuse Cervical System2P382P382019-04-24
00810016800149Accufuse Cervical System2P412P412019-04-24
00810016800156Accufuse Cervical System2P442P442019-04-24
00810016800163Accufuse Cervical System1P7P81P7P82019-04-24
00810016800170Accufuse Cervical System1P9P101P9P102019-04-24
00810016800187Accufuse Cervical System1P11P121P11P122019-04-24
00810016800194Accufuse Cervical System1P13P141P13P142019-04-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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