| Primary Device ID | B922A00474350 |
| NIH Device Record Key | 599e11eb-7b1a-4b49-b291-e075f47f0c9e |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACURA Stabilization System Ø 7.5 x 35 mm Polyaxial Screw - NT |
| Version Model Number | A004.7435 |
| Catalog Number | A004.7435 |
| 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 |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Outer Diameter | 7.5 Millimeter |
| Length | 35 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | B922A00474350 [Primary] |
| NKB | Thoracolumbosacral Pedicle Screw System |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
[B922A00474350]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2022-10-20 |
| Device Publish Date | 2022-10-12 |
| B922F004800208 - ACURA Stabilization System | 2026-03-19 T20 Connector Driver ( Silicone Handle) |
| 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 |