ACURA Stabilization System Non-Threaded Locking Cap A004.4001

GUDID B922A00440010

ACURA Stabilization System Non-Threaded Locking Cap

INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED

Bone-screw internal spinal fixation system, non-sterile
Primary Device IDB922A00440010
NIH Device Record Key87bf404e-10ed-4d2f-89bc-02d4de836723
Commercial Distribution StatusIn Commercial Distribution
Brand NameACURA Stabilization System Non-Threaded Locking Cap
Version Model NumberA004.4001
Catalog NumberA004.4001
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

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB922A00440010 [Primary]

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B922A00440010]

Moist Heat or Steam Sterilization

[B922A00440010]

Moist Heat or Steam Sterilization

[B922A00440010]

Moist Heat or Steam Sterilization

[B922A00440010]

Moist Heat or Steam Sterilization

[B922A00440010]

Moist Heat or Steam Sterilization

[B922A00440010]

Moist Heat or Steam Sterilization

[B922A00440010]

Moist Heat or Steam Sterilization

[B922A00440010]

Moist Heat or Steam Sterilization

[B922A00440010]

Moist Heat or Steam Sterilization

[B922A00440010]

Moist Heat or Steam Sterilization

[B922A00440010]

Moist Heat or Steam Sterilization

[B922A00440010]

Moist Heat or Steam Sterilization

[B922A00440010]

Moist Heat or Steam Sterilization

[B922A00440010]

Moist Heat or Steam Sterilization

[B922A00440010]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-10-19
Device Publish Date2022-10-11

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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
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