Asfora Anterior Cervical Plate System

GUDID 11110629

Variable Angle Drill Guide

MEDICAL DESIGNS LLC

Surgical drill guide, reusable
Primary Device ID11110629
NIH Device Record Keya9404937-7084-4350-827a-5689c797d054
Commercial Distribution StatusIn Commercial Distribution
Brand NameAsfora Anterior Cervical Plate System
Version Model Number11-1106-FD29
Company DUNS003815548
Company NameMEDICAL DESIGNS LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCC11110629 [Direct Marking]
HIBCCM364111106FD290 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[11110629]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number5
Public Version Date2020-04-06
Device Publish Date2016-09-27

On-Brand Devices [Asfora Anterior Cervical Plate System]

111106273Screw Extractor Wedge Lock
111106272Screw Extractor Driver
111106271Screw Extractor Sleeve
11110641Fixed Angle Drill Guide
11110629Variable Angle Drill Guide
11110643Axial Driver Handle
11110642Axial Drill Bit Handle
1111064944 Level, 94mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
1111064904 Level, 90mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
1111064864 Level, 86mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
1111064824 Level, 82mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
1111064784 Level, 78mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
1111064744 Level, 74mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
1111063753 Level, 75mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
1111063723 Level, 72mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
1111063693 Level, 69mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
1111063663 Level, 66mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
1111063633 Level, 63mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
1111063603 Level, 60mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
1111063573 Level, 57mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
1111063543 Level, 54mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
1111063513 Level, 51mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
1111062502 Level, 50mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
1111062472 Level, 47mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
1111062442 Level, 44mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
1111062412 Level, 41mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
1111062382 Level, 38mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
1111062352 Level, 35mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
1111062322 Level, 32mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
1111061341 Level, 34mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
1111061321 Level, 32mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
1111061301 Level, 30mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
1111061281 Level, 28mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
1111061261 Level, 26mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
1111061241 Level, 24mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
1111061221 Level, 22mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t
M364111106FD12001 Level, 20mm Cervical Plate; The Asfora Anterior Cervical Plate System is intended to provide t

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