Asfora Anterior Cervical Plate System

Primary DI
M364111106FD1200
Brand
Asfora Anterior Cervical Plate System
Company
MEDICAL DESIGNS LLC
Model
11-1106-FD1-20
Device description
1 Level, 20mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide temporarystabilization to the anterior spine during the development of cervical spinefusions (C2-T1) for the following indications: degenerative disc disease (DDD)(defined as neck pain of discogenic origin with degeneration of the discconfirmed by history and radiographic studies), spondylolisthesis, trauma (i.e.,fracture or dislocation), spinal stenosis, deformities or curvatures (i.e., scoliosis,kyphosis, and/or lordosis), tumor, pseudoarthrosis, and failed previous fusion.
Published
2016-09-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

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

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143688000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143688000ASFORA ANTERIOR CERVICAL PLATE SYSTEMMedical Designs, LLC2015-07-01KWQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
111106120Direct MarkingHIBCC0
M364111106FD1200PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Spinal fixation plate, non-bioabsorbableA small, implantable, non-customized sheet of solid material intended to be attached to the spine with screws for spinal immobilization; 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 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

Contacts#

Phone, Email table
PhoneEmail
605-275-1032kspielman@medicaldesignsllc.com

Regulatory Flags#

DUNS number
003815548
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M364111106FD1220Asfora Anterior Cervical Plate System11-1106-FD1-222016-09-27
M364111106FD1240Asfora Anterior Cervical Plate System11-1106-FD1-242016-09-27
M364111106FD1260Asfora Anterior Cervical Plate System11-1106-FD1-262016-09-27
M364111106FD1280Asfora Anterior Cervical Plate System11-1106-FD1-282016-09-27
M364111106FD1300Asfora Anterior Cervical Plate System11-1106-FD1-302016-09-27
M364111106FD1320Asfora Anterior Cervical Plate System11-1106-FD1-322016-09-27
M364111106FD1340Asfora Anterior Cervical Plate System11-1106-FD1-342016-09-27
M364111106FD2320Asfora Anterior Cervical Plate System11-1106-FD2-322016-09-27
M364111106FD2350Asfora Anterior Cervical Plate System11-1106-FD2-352016-09-27
M364111106FD2380Asfora Anterior Cervical Plate System11-1106-FD2-382016-09-27
M364111106FD2410Asfora Anterior Cervical Plate System11-1106-FD2-412016-09-27
M364111106FD2440Asfora Anterior Cervical Plate System11-1106-FD2-442016-09-27
M364111106FD2470Asfora Anterior Cervical Plate System11-1106-FD2-472016-09-27
M364111106FD2500Asfora Anterior Cervical Plate System11-1106-FD2-502016-09-27
M364111106FD350Asfora Anterior Cervical Plate System11-1106-FD352016-09-27
M364111106FD3510Asfora Anterior Cervical Plate System11-1106-FD3-512016-09-27
M364111106FD3540Asfora Anterior Cervical Plate System11-1106-FD3-542016-09-27
M364111106FD3570Asfora Anterior Cervical Plate System11-1106-FD3-572016-09-27
M364111106FD3600Asfora Anterior Cervical Plate System11-1106-FD3-602016-09-27
M364111106FD3630Asfora Anterior Cervical Plate System11-1106-FD3-632016-09-27

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