FDA.report

Accufuse Cervical System

Primary DI
00810016800613
Brand
Accufuse Cervical System
Company
ABSOLUTE ADVANTAGE MEDICAL, LLC
Model
FB4516
Catalog number
FB4516
Device description
Cervical Screw Fixed 4.5x16mm Blunt
Published
2019-04-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
KWQAppliance, Fixation, Spinal Intervertebral Body

Product Code Classifications

CodeDeviceSpecialtyClass
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00810016800613PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00810016800613008100168006138100168006130810016800613

GMDN Terms

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
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
056248579
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00810016801313Accufuse Cervical SystemC161407C1614072019-12-31
00810016801290Accufuse Cervical SystemC161405C1614052019-12-31
00810016801306Accufuse Cervical SystemC161406C1614062019-12-31
00810016801320Accufuse Cervical SystemC161408C1614082019-12-31
00810016801337Accufuse Cervical SystemC161409C1614092019-12-31
00810016801344Accufuse Cervical SystemC161410C1614102019-12-31
00810016801351Accufuse Cervical SystemC161411C1614112019-12-31
00810016801368Accufuse Cervical SystemC161412C1614122019-12-31
00810016801375Accufuse Cervical SystemC181505C1815052019-12-31
00810016801382Accufuse Cervical SystemC181506C1815062019-12-31
00810016801399Accufuse Cervical SystemC181507C1815072019-12-31
00810016801405Accufuse Cervical SystemC181508C1815082019-12-31
00810016801412Accufuse Cervical SystemC181509C1815092019-12-31
00810016801436Accufuse Cervical SystemC181510C1815102019-12-31
00810016801443Accufuse Cervical SystemC181511C1815112019-12-31
00810016801450Accufuse Cervical SystemC181512C1815122019-12-31
00810016800644Accufuse Cervical SystemC121205C1212052019-04-24
00810016800651Accufuse Cervical SystemC121206C1212062019-04-24
00810016800668Accufuse Cervical SystemC121207C1212072019-04-24
00810016800675Accufuse Cervical SystemC121208C1212082019-04-24

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00840283402197VyPlate™VY SPINE LLCKWQ2026-03-19
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