V3™ Segmental Plating System 1121-01-0015

GUDID M68111210100150

15mm Plate Assembly

ATLAS SPINE, INC.

Spinal fixation plate, non-bioabsorbable
Primary Device IDM68111210100150
NIH Device Record Key1acb2248-6221-41f6-835e-2a9448a8993b
Commercial Distribution StatusIn Commercial Distribution
Brand NameV3™ Segmental Plating System
Version Model Number1121-01-0015
Catalog Number1121-01-0015
Company DUNS140801007
Company NameATLAS SPINE, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Dimensions

Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter
Length15 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCM68111210100150 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KWQAppliance, Fixation, Spinal Intervertebral Body

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[M68111210100150]

Moist Heat or Steam Sterilization


[M68111210100150]

Moist Heat or Steam Sterilization


[M68111210100150]

Moist Heat or Steam Sterilization


[M68111210100150]

Moist Heat or Steam Sterilization


[M68111210100150]

Moist Heat or Steam Sterilization


[M68111210100150]

Moist Heat or Steam Sterilization


[M68111210100150]

Moist Heat or Steam Sterilization


[M68111210100150]

Moist Heat or Steam Sterilization


[M68111210100150]

Moist Heat or Steam Sterilization


[M68111210100150]

Moist Heat or Steam Sterilization


[M68111210100150]

Moist Heat or Steam Sterilization


[M68111210100150]

Moist Heat or Steam Sterilization


[M68111210100150]

Moist Heat or Steam Sterilization


[M68111210100150]

Moist Heat or Steam Sterilization


[M68111210100150]

Moist Heat or Steam Sterilization


[M68111210100150]

Moist Heat or Steam Sterilization


[M68111210100150]

Moist Heat or Steam Sterilization


[M68111210100150]

Moist Heat or Steam Sterilization


[M68111210100150]

Moist Heat or Steam Sterilization


[M68111210100150]

Moist Heat or Steam Sterilization


[M68111210100150]

Moist Heat or Steam Sterilization


[M68111210100150]

Moist Heat or Steam Sterilization


[M68111210100150]

Moist Heat or Steam Sterilization


[M68111210100150]

Moist Heat or Steam Sterilization


[M68111210100150]

Moist Heat or Steam Sterilization


[M68111210100150]

Moist Heat or Steam Sterilization


[M68111210100150]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-01
Device Publish Date2020-09-23

On-Brand Devices [V3™ Segmental Plating System]

M6811121040016016mm Rescue Screw
M6811121040014014mm Rescue Screw
M6811121040012012mm Rescue Screw
M6811121030016016mm Fixed Screw
M6811121030014014mm Fixed Screw
M6811121030012012mm Fixed Screw
M6811121020016016mm Variable Screw
M6811121020014014mm Variable Screw
M6811121020012012mm Variable Screw
M6811121010017017mm Plate Assembly
M6811121010015015mm Plate Assembly
M6811121010013013mm Plate Assembly
M6811121010011011mm Plate Assembly
M681112101000909mm Plate Assembly

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