FDA.reportPublic FDA data

Asfora Anterior Cervical Plate System

Primary DI
M364111106FD2320
Brand
Asfora Anterior Cervical Plate System
Company
MEDICAL DESIGNS LLC
Model
11-1106-FD2-32
Device description
2 Level, 32mm 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
2016-09-27
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
111106232Direct MarkingHIBCC0
M364111106FD2320PrimaryHIBCC0

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 as part of treatment of a spinal instability or deformity; 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). Disposable instruments intended to facilitate implantation, or fixation implants (i.e., bone screws), may be packaged with the plate.

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
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
M364111106FD3660Asfora Anterior Cervical Plate System11-1106-FD3-662016-09-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840354204958Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354204965Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354204972Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354204989Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354204996Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205009Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205016Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205023Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205030Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205047Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205054Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205061Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205078Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205085Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205092Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205108Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205115Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205122Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205139Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205146Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205153Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205160Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205177Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205184Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205191Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354205207Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-07
00840354203654Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203661Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203678Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06
00840354203685Impeace Cervical Plate SystemMEDYNUS, INC.KWQ2026-05-06