ACURA Stabilization System- Cross Connector, 58-71 mm A004.5871

GUDID B922A00458710

Cross Connector 58-71 mm

INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED

Bone-screw internal spinal fixation system, non-sterile
Primary Device IDB922A00458710
NIH Device Record Key2c04af3f-e0c7-4a3f-8301-027f3247baec
Commercial Distribution StatusIn Commercial Distribution
Brand NameACURA Stabilization System- Cross Connector, 58-71 mm
Version Model NumberA004.5871
Catalog NumberA004.5871
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
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
HIBCCB922A00458710 [Primary]

FDA Product Code

NKBThoracolumbosacral Pedicle Screw System

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

[B922A00458710]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-17
Device Publish Date2023-08-09

Devices Manufactured by INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED

B922F004800208 - ACURA Stabilization System2026-03-19 T20 Connector Driver ( Silicone Handle)
B922F005001505 - Acura Stabilization System2026-03-19 Long tab breaker (Nose Plier Type)
B922F005001707 - ACURA Stabilization System2026-03-19 Counter Torque, Long Tab Screw
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
© 2026 FDA.report
This site is not affiliated with or endorsed by the FDA.