| Primary Device ID | G832F00503650 |
| NIH Device Record Key | 218ad5c2-67d6-4b44-93a2-f8a6271a1c00 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | ACURA Stabilization System |
| Version Model Number | F005.0365 |
| Catalog Number | F005.0365 |
| Company DUNS | 111818362 |
| Company Name | Bioalign Inc. |
| Device Count | 1 |
| DM Exempt | true |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | false |
| 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 |
| admin@bioalignusa.com | |
| Phone | +1(214)972-8683 |
| admin@bioalignusa.com | |
| Phone | +1(214)972-8683 |
| admin@bioalignusa.com | |
| Phone | +1(214)972-8683 |
| admin@bioalignusa.com | |
| Phone | +1(214)972-8683 |
| admin@bioalignusa.com | |
| Phone | +1(214)972-8683 |
| admin@bioalignusa.com | |
| Phone | +1(214)972-8683 |
| admin@bioalignusa.com |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Outer Diameter | 6.5 Millimeter |
| Device Issuing Agency | Device ID |
|---|---|
| HIBCC | G832F00503650 [Primary] |
| HWX | Tap, Bone |
| Steralize Prior To Use | true |
| Device Is Sterile | false |
[G832F00503650]
Moist Heat or Steam Sterilization
[G832F00503650]
Moist Heat or Steam Sterilization
[G832F00503650]
Moist Heat or Steam Sterilization
[G832F00503650]
Moist Heat or Steam Sterilization
[G832F00503650]
Moist Heat or Steam Sterilization
[G832F00503650]
Moist Heat or Steam Sterilization
[G832F00503650]
Moist Heat or Steam Sterilization
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2026-03-17 |
| Device Publish Date | 2026-03-09 |
| G832F00503650 | Cannulated Tap Dia.6.5mm |
| G832F00503550 | Cannulated Tap Dia.5.5mm |
| G832F00503450 | Cannulated Tap Dia.4.5mm |
| G832F00503040 | Rigid Driver, Long Tab Screw |
| G832F005010308 | Dilator-3 |
| G832F005010207 | Dilator-2 |
| G832F005010106 | Dilator-1 |
| G832F00500340 | Rachet Driver |
| G832F00500330 | Screw Head Tubes |
| G832F005003108 | MIS Compressor |
| G832F005003007 | Guidewire (Threaded) |
| G832F00500090 | Rod Inserter Threaded Shaft |
| G832F00500080 | Rod Inserter Sleeve |
| G832A00540000 | Locking Cap Cannulated Screw |
| G832A00531500 | 5.5 x 150 mm TAV Straight Rod, Square End |
| G832A00531300 | 5.5 x 130 mm TAV Straight Rod, Square End |
| G832A00531200 | 5.5 x 120 mm TAV Straight Rod, Square End |
| G832A00531100 | 5.5 x 110 mm TAV Straight Rod, Square End |
| G832A00531000 | 5.5 x 100 mm TAV Straight Rod, Square End |
| G832A00530900 | 5.5 x 90 mm TAV Straight Rod, Square End |
| G832A00520850 | 5.5 x 85 mm TAV Curved Rod, Square End |
| G832A00520800 | 5.5 x 80 mm TAV Curved Rod, Square End |
| G832A00520750 | 5.5 x 75 mm TAV Curved Rod, Square End |
| G832A00520700 | 5.5 x 70 mm TAV Curved Rod, Square End |
| G832A00520650 | 5.5 x 65 mm TAV Curved Rod, Square End |
| G832A00520600 | 5.5 x 60 mm TAV Curved Rod, Square End |
| G832A00520550 | 5.5 x 55 mm TAV Curved Rod, Square End |
| G832A00520500 | 5.5 x 50 mm TAV Curved Rod, Square End |
| G832A00520450 | 5.5 x 45 mm TAV Curved Rod, Square End |
| G832A00520400 | 5.5 x 40 mm TAV Curved Rod, Square End |
| G832A00514500 | 7.5 x 50mm Cannulated Long Tab Polyaxial Screw |
| G832A00514450 | 7.5 x 45mm Cannulated Long Tab Polyaxial Screw |
| G832A00514400 | 7.5 x 40mm Cannulated Long Tab Polyaxial Screw |
| G832A00514350 | 7.5 x 35mm Cannulated Long Tab Polyaxial Screw |
| G832A00513500 | 6.5 x 50mm Cannulated Long Tab Polyaxial Screw |
| G832A00513450 | 6.5 x 45mm Cannulated Long Tab Polyaxial Screw |
| G832A00513400 | 6.5 x 40 mm Cannulated Long Tab Polyaxial Screw |
| G832A00513350 | 6.5 x 35 mm Cannulated Long Tab Polyaxial Screw |
| G832A00512500 | 5.5 x 50 mm Cannulated Long Tab Polyaxial Screw |
| G832A00512450 | 5.5 x 45 mm Cannulated Long Tab Polyaxial Screw |
| G832A00512400 | 5.5 x 40 mm Cannulated Long Tab Polyaxial Screw |
| G832A00512350 | 5.5x35mm Cannulated Long Tab Polyaxial Screw |
| G832A00512300 | 5.5x30mm Cannulated Long Tab Polyaxial Screw |
| G832A00475550 | Polyaxial Screw Assembly Ø 8.5 x 55 mm NT |
| G832A00475350 | Polyaxial Screw Assembly Ø 8.5 x 35 mm NT |
| G832A00474600 | Polyaxial Screw Assembly Ø 7.5 x 60 mm NT |
| G832A00474550 | Polyaxial Screw Assembly Ø 7.5 x 55 mm NT |
| G832A00474500 | Polyaxial Screw Assembly Ø 7.5 x 50 mm NT |
| G832A00474450 | Polyaxial Screw Assembly Ø 7.5 x 45 mm NT |
| G832A00474400 | Polyaxial Screw Assembly Ø 7.5 x 40 mm NT |