ACURA Stabilization System - Rod Lever/ Reduction Fork F004.0027

GUDID B922F00400270

Rod Lever/ Reduction Fork

INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED

Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable Internal spinal fixation procedure kit, reusable
Primary Device IDB922F00400270
NIH Device Record Key9888a7de-559f-4311-ae62-081aedde58b6
Commercial Distribution StatusIn Commercial Distribution
Brand NameACURA Stabilization System - Rod Lever/ Reduction Fork
Version Model NumberF004.0027
Catalog NumberF004.0027
Company DUNS860396609
Company NameINDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB922F00400270 [Primary]

FDA Product Code

HXEFork

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B922F00400270]

Moist Heat or Steam Sterilization

[B922F00400270]

Moist Heat or Steam Sterilization

[B922F00400270]

Moist Heat or Steam Sterilization

[B922F00400270]

Moist Heat or Steam Sterilization

[B922F00400270]

Moist Heat or Steam Sterilization

[B922F00400270]

Moist Heat or Steam Sterilization

[B922F00400270]

Moist Heat or Steam Sterilization

[B922F00400270]

Moist Heat or Steam Sterilization

[B922F00400270]

Moist Heat or Steam Sterilization

[B922F00400270]

Moist Heat or Steam Sterilization

[B922F00400270]

Moist Heat or Steam Sterilization

[B922F00400270]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-03-29
Device Publish Date2022-03-21

Devices Manufactured by INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED

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B922F00400780 - Screw Head Positioner2024-04-09 Screw Head Positioner
B922F00403270 - ACURA Stabilization System - Rigid Screw Driver,SNAP ON (NT)2024-04-05 Rigid Screw Driver, SNAP ON (NT)
B922A00471350 - ACURA Stabilization System Ø 4.5 x 35 mm Polyaxial Screw - NT2024-03-26 ACURA Stabilization System Ø 4.5 x 35 mm Polyaxial Screw - NT
B922A00471400 - ACURA Stabilization System Ø 4.5 x 40 mm Polyaxial Screw - NT2024-03-26 ACURA Stabilization System Ø 4.5 x 40 mm Polyaxial Screw - NT
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
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