FDA.reportPublic FDA data

Asfora Anterior Cervical Plate System

Primary DI
M364111106FD420
Brand
Asfora Anterior Cervical Plate System
Company
MEDICAL DESIGNS LLC
Model
11-1106-FD42
Device description
Axial Drill Bit Handle
Published
2016-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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
11110642Direct MarkingHIBCC0
M364111106FD420PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Manual surgical rotary handpiece, reusableA manually-powered, hand-held, surgical device intended to be used to provide rotary motion for an endpiece (not included) during a surgical procedure such as cutting, sculpting, trepanning, or drilling bone and driving Kirschner wires; it is not dedicated to a specific clinical procedure. It is available in two main designs: 1) a U-shaped drill brace powered by the surgeon who holds the top of the brace steady whilst rotating it with horizontal crankshaft-like movements; or 2) a drill powered by the rotation of a side-mounted handle, and which may be cannulated to allow for use of a guidewire. Both types may have a Jacobs chuck or collet to hold the drill bit. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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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Primary DI, Brand, Company table
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