ACURA Stabilization System Ø 5.5 x 55 mm Cannulated Polyaxial Screw - NT A004.7255

GUDID B922A00472550

ACURA Stabilization System Ø 5.5 x 55 mm Cannulated Polyaxial Screw - NT

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
Primary Device IDB922A00472550
NIH Device Record Key087870ba-cae1-46f0-8d31-6e1fff64d6c2
Commercial Distribution StatusIn Commercial Distribution
Brand NameACURA Stabilization System Ø 5.5 x 55 mm Cannulated Polyaxial Screw - NT
Version Model NumberA004.7255
Catalog NumberA004.7255
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+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com
Phone+1(214)972-8683
Emailinfo@indiusmedical.com

Device Dimensions

Outer Diameter5.5 Millimeter
Length55 Millimeter
Outer Diameter5.5 Millimeter
Length55 Millimeter
Outer Diameter5.5 Millimeter
Length55 Millimeter
Outer Diameter5.5 Millimeter
Length55 Millimeter
Outer Diameter5.5 Millimeter
Length55 Millimeter
Outer Diameter5.5 Millimeter
Length55 Millimeter
Outer Diameter5.5 Millimeter
Length55 Millimeter
Outer Diameter5.5 Millimeter
Length55 Millimeter
Outer Diameter5.5 Millimeter
Length55 Millimeter
Outer Diameter5.5 Millimeter
Length55 Millimeter
Outer Diameter5.5 Millimeter
Length55 Millimeter
Outer Diameter5.5 Millimeter
Length55 Millimeter
Outer Diameter5.5 Millimeter
Length55 Millimeter
Outer Diameter5.5 Millimeter
Length55 Millimeter
Outer Diameter5.5 Millimeter
Length55 Millimeter
Outer Diameter5.5 Millimeter
Length55 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB922A00472550 [Primary]

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B922A00472550]

Moist Heat or Steam Sterilization


[B922A00472550]

Moist Heat or Steam Sterilization


[B922A00472550]

Moist Heat or Steam Sterilization


[B922A00472550]

Moist Heat or Steam Sterilization


[B922A00472550]

Moist Heat or Steam Sterilization


[B922A00472550]

Moist Heat or Steam Sterilization


[B922A00472550]

Moist Heat or Steam Sterilization


[B922A00472550]

Moist Heat or Steam Sterilization


[B922A00472550]

Moist Heat or Steam Sterilization


[B922A00472550]

Moist Heat or Steam Sterilization


[B922A00472550]

Moist Heat or Steam Sterilization


[B922A00472550]

Moist Heat or Steam Sterilization


[B922A00472550]

Moist Heat or Steam Sterilization


[B922A00472550]

Moist Heat or Steam Sterilization


[B922A00472550]

Moist Heat or Steam Sterilization


[B922A00472550]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-20
Device Publish Date2022-10-12

On-Brand Devices [ACURA Stabilization System Ø 5.5 x 55 mm Cannulated Polyaxial Screw - NT]

B922A00472550ACURA Stabilization System Ø 5.5 x 55 mm Cannulated Polyaxial Screw - NT
B922A00572550ACURA Stabilization System Ø 5.5 x 55 mm Cannulated Polyaxial Screw - NT

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