Asfora Anterior Cervical Plate System

Primary DI
M364111106FD7160
Brand
Asfora Anterior Cervical Plate System
Company
MEDICAL DESIGNS LLC
Model
11-1106-FD7-16
Device description
16mm Variable Angle Locking Screw
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
111106716Direct MarkingHIBCC0
M364111106FD7160PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterile"A small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A ""lag screw"" can be any of these used to obtain compression. This device must be sterilized prior to use."

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840493424712RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424729RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424736RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424743RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424750RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424767RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424774RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424781RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424798RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424804RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424811RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424828RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424835RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424842RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424859RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424866RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424873RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424880RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424897RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424903RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424910RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424927RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424934RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424941RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424958RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424965RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424972RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424989RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493424996RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13
00840493425009RIVA Pedicle Screw SystemXENIX MEDICAL LLCKWQ2026-07-13