| Primary Device ID | B922A00476500 |
| NIH Device Record Key | fb089446-6f7b-4ee1-b789-07afe0e1065f |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACURA Stabilization System Ø 9.5 x 50 mm Polyaxial Screw - NT |
| Version Model Number | A004.7650 |
| Catalog Number | A004.7650 |
| Company DUNS | 860396609 |
| Company Name | INDIUS MEDICAL TECHNOLOGIES PRIVATE LIMITED |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | false |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | true |
| Lot Batch | true |
| Serial Number | false |
| Manufacturing Date | false |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | true |
| OTC Over-The-Counter | false |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com | |
| Phone | +1(214)972-8683 |
| info@indiusmedical.com |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Outer Diameter | 9.5 Millimeter |
| Length | 50 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B922A00476500 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
[B922A00476500]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-08-16 |
| Device Publish Date | 2023-08-08 |
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| B922F005001505 - Acura Stabilization System | 2026-03-19 Long tab breaker (Nose Plier Type) |
| B922F005001707 - ACURA Stabilization System | 2026-03-19 Counter Torque, Long Tab Screw |
| B922F005001808 - ACURA Stabilization System | 2026-03-19 Rod Confirmer |
| B922F005003608 - ACURA Stabilization System | 2026-03-19 Long Tab Compressor |
| B922F005003709 - ACURA Stabilization System | 2026-03-19 Long Tab Distractor |
| B922F00500380 - ACURA Stabilization System | 2026-03-19 Guidewire Extractor |
| B922F00500390 - ACURA Stabilization System | 2026-03-19 Long Tab Cutter |