FDA.reportPublic FDA data

Accufuse Cervical System

Primary DI
00810016800286
Brand
Accufuse Cervical System
Company
ABSOLUTE ADVANTAGE MEDICAL, LLC
Model
VS4020
Catalog number
VS4020
Device description
Cervical Screw Variable 4.0x20mm Sharp
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
00810016800286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810016800286008100168002868100168002860810016800286

GMDN Terms#

Term, Definition table
TermDefinition
Spinal bone screw, non-bioabsorbableA small, sterile, threaded rod with a slotted head intended to be used for internal spinal fixation by being screwed into the spine to hold plates, or other stabilization device, to bone; it 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 available in various types, including pedicle and transfacet, and is typically used to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities.

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
Expiration 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
00810016800002Accufuse Cervical System1P7C51P7C52019-04-24
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840466901035PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901042PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901059PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901066PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901073PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901080PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901097PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901103PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901110PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901127PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901141PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901158PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901165PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901172PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901479PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901486PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901493PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901509PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901516PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901523PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901530PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901547PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901554PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901561PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901578PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901585PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901592PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901608PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901615PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21
00840466901622PrimusSPINAL ELEMENTS, INC.KWQ2026-07-21