ACURA Stabilization System 8.5mm x 60mm Polyaxial Screw A004.0560

GUDID B922A00405600

ACURA Stabilization System 8.5mm x 60mm Polyaxial Screw

INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device IDB922A00405600
NIH Device Record Keye5d0bc11-41b5-4d58-ac7c-b169c6fc9650
Commercial Distribution StatusIn Commercial Distribution
Brand NameACURA Stabilization System 8.5mm x 60mm Polyaxial Screw
Version Model NumberA004.0560
Catalog NumberA004.0560
Company DUNS860396609
Company NameINDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED
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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com
Phone+1214-972-8683
Emailinfo@indiusmedical.com

Device Dimensions

Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter
Outer Diameter8.5 Millimeter
Length60 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB922A00405600 [Primary]

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B922A00405600]

Moist Heat or Steam Sterilization


[B922A00405600]

Moist Heat or Steam Sterilization


[B922A00405600]

Moist Heat or Steam Sterilization


[B922A00405600]

Moist Heat or Steam Sterilization


[B922A00405600]

Moist Heat or Steam Sterilization


[B922A00405600]

Moist Heat or Steam Sterilization


[B922A00405600]

Moist Heat or Steam Sterilization


[B922A00405600]

Moist Heat or Steam Sterilization


[B922A00405600]

Moist Heat or Steam Sterilization


[B922A00405600]

Moist Heat or Steam Sterilization


[B922A00405600]

Moist Heat or Steam Sterilization


[B922A00405600]

Moist Heat or Steam Sterilization


[B922A00405600]

Moist Heat or Steam Sterilization


[B922A00405600]

Moist Heat or Steam Sterilization


[B922A00405600]

Moist Heat or Steam Sterilization


[B922A00405600]

Moist Heat or Steam Sterilization


[B922A00405600]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-23
Device Publish Date2023-03-15

Devices Manufactured by INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED

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B922A00471450 - ACURA Stabilization System Ø 4.5 x 45 mm Polyaxial Screw - NT2024-03-26 ACURA Stabilization System Ø 4.5 x 45 mm Polyaxial Screw - NT
B922F00300210 - Alignment Jig2023-11-09 Alignment Jig
B922F00300230 - Alignment Instrument Prongs Assembly2023-11-09 Alignment Instrument Prongs Assembly
B922F00300010 - Bone Drill2023-08-21 Bone Drill
B922F00403350 - ACURA Stabilization System - Cap Driver, Non Threaded2023-08-21 Cap Driver, NT
B922F004004709 - Parallel Compressor2023-08-18 Parallel Compressor

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