V3” Segmental Plating System 1121-05-0018

GUDID M68111210500180

18mm Four Hole Plate Assembly, V3™ Segmental Plating System

ATLAS SPINE, INC.

Spinal fixation plate, non-bioabsorbable
Primary Device IDM68111210500180
NIH Device Record Key238441eb-9647-4fdd-b85c-8585e1a493e7
Commercial Distribution StatusIn Commercial Distribution
Brand NameV3” Segmental Plating System
Version Model Number1121-05-0018
Catalog Number1121-05-0018
Company DUNS140801007
Company NameATLAS SPINE, INC.
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length18 Millimeter
Length18 Millimeter
Length18 Millimeter
Length18 Millimeter
Length18 Millimeter
Length18 Millimeter
Length18 Millimeter
Length18 Millimeter
Length18 Millimeter
Length18 Millimeter
Length18 Millimeter
Length18 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM68111210500180 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M68111210500180]

Moist Heat or Steam Sterilization


[M68111210500180]

Moist Heat or Steam Sterilization


[M68111210500180]

Moist Heat or Steam Sterilization


[M68111210500180]

Moist Heat or Steam Sterilization


[M68111210500180]

Moist Heat or Steam Sterilization


[M68111210500180]

Moist Heat or Steam Sterilization


[M68111210500180]

Moist Heat or Steam Sterilization


[M68111210500180]

Moist Heat or Steam Sterilization


[M68111210500180]

Moist Heat or Steam Sterilization


[M68111210500180]

Moist Heat or Steam Sterilization


[M68111210500180]

Moist Heat or Steam Sterilization


[M68111210500180]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-08-26
Device Publish Date2024-08-16

On-Brand Devices [V3” Segmental Plating System]

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M6811121050018018mm Four Hole Plate Assembly, V3™ Segmental Plating System
M6811121050017017mm Four Hole Plate Assembly, V3™ Segmental Plating System
M6811121050016016mm Four Hole Plate Assembly, V3™ Segmental Plating System
M6811121050015015mm Four Hole Plate Assembly, V3™ Segmental Plating System
M6811121050014014mm Four Hole Plate Assembly, V3™ Segmental Plating System
M6811121050013013mm Four Hole Plate Assembly, V3™ Segmental Plating System
M6811121050012012mm Four Hole Plate Assembly, V3™ Segmental Plating System
M6811121050011011mm Four Hole Plate Assembly, V3™ Segmental Plating System
M6811121050010010mm Four Hole Plate Assembly, V3™ Segmental Plating System
M681112105000909mm Four Hole Plate Assembly, V3™ Segmental Plating System
M681112105000808mm Four Hole Plate Assembly, V3™ Segmental Plating System

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