ACURA Stabilization System Ø 6.5 x 55 mm Polyaxial Screw - NT A004.7355

GUDID B922A00473550

ACURA Stabilization System Ø 6.5 x 55 mm Polyaxial Screw - NT

INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED

Bone-screw internal spinal fixation system, non-sterile
Primary Device IDB922A00473550
NIH Device Record Key07cbfbd3-5a96-47aa-a17b-0520e090b1b1
Commercial Distribution StatusIn Commercial Distribution
Brand NameACURA Stabilization System Ø 6.5 x 55 mm Polyaxial Screw - NT
Version Model NumberA004.7355
Catalog NumberA004.7355
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
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
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 Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter
Outer Diameter6.5 Millimeter
Length55 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB922A00473550 [Primary]

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

Moist Heat or Steam Sterilization


[B922A00473550]

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

Devices Manufactured by INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED

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B922F005001808 - ACURA Stabilization System2026-03-19 Rod Confirmer
B922F005003608 - ACURA Stabilization System2026-03-19 Long Tab Compressor
B922F005003709 - ACURA Stabilization System2026-03-19 Long Tab Distractor
B922F00500380 - ACURA Stabilization System2026-03-19 Guidewire Extractor
B922F00500390 - ACURA Stabilization System2026-03-19 Long Tab Cutter

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