Question 1

What types of medical devices does Indius Medical Technologies manufacture?

Accepted Answer

Indius Medical Technologies specializes in reusable spinal surgical instruments and non-bioabsorbable spinal fixation hardware. Their product line includes spinal bone screws (such as variable-angle and polyaxial screws), spinal fixation plates, internal spinal fixation rods, connectors, bone taps, screwdrivers, and trial-implant holders. These devices are designed for procedures like anterior cervical stabilization and internal spinal fixation, ensuring secure alignment and support during surgery.

Question 2

Where is Indius Medical Technologies based?

Accepted Answer

Indius Medical Technologies is headquartered in the United States. The company operates from within the US, where its devices are developed, manufactured, and regulated under applicable US medical device laws.

Question 3

Which regulatory registries list Indius Medical Technologies’ devices?

Accepted Answer

Indius Medical Technologies’ devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for spinal fixation hardware and reusable surgical instruments, allowing healthcare providers and regulators to identify and verify the devices in compliance with US medical device regulations.

Question 4

How are Indius Medical Technologies’ devices classified under FDA regulations?

Accepted Answer

Indius Medical Technologies’ devices fall under FDA’s Class I and Class II categories. Class I devices generally pose minimal risk and may be exempt from certain regulatory controls, while Class II devices require special controls to ensure their safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and the body area involved, such as spinal fixation hardware.

Question 5

What distinguishes Indius Medical Technologies’ reusable spinal surgical instruments from other manufacturers?

Accepted Answer

Indius Medical Technologies’ reusable instruments are designed for durability and precision in spinal procedures, including self-drilling screws, bone taps, and specialized screwdrivers. Their focus on reusable tools reduces waste and cost while maintaining high performance. Additionally, their non-bioabsorbable spinal fixation hardware, like polyaxial screws and connectors, is engineered for long-term stability in spinal stabilization systems, catering to specific surgical needs like anterior cervical procedures.

Device	Model / Reference	Registries	Class	Status
ACURA Stabilization System Ø 7.5 x 40 mm Polyaxial Screw - NT	A004.7440	FDA UDI	Class II	Active
ACURA Stabilization System- Cross Connector, 58-71 mm	A004.5871	FDA UDI	Class II	Active
ACURA Stabilization System - Tower Reducer Wrench	F004.0026	FDA UDI	Class I	Active
ACURA Stabilization System - Rod Holder	F004.0003	FDA UDI	Class I	Active
ACURA Stabilization System Ø 4.5 x 30 mm Polyaxial Screw - NT	A004.7130	FDA UDI	Class II	Active
ACURA Stabilization System - Straight Lenke Probe	F004.0115	FDA UDI	Class I	Active
ACURA Stabilization System	A004.4000	FDA UDI	Class II	Active
ACURA Stabilization System Ø 7.5 x 60 mm Polyaxial Screw - NT	A004.7460	FDA UDI	Class II	Active
SEA-LINK Anterior Cervical Plate System	A003.0485	FDA UDI	Class II	Active
SEA-LINK Anterior Cervical Plate System	A003.0354	FDA UDI	Class II	Active
ACURA Stabilization System	A004.3125	FDA UDI	Class II	Active
ACURA Stabilization System Ø 5.5 x 55 mm Cannulated Polyaxial Screw - NT	A005.7255	FDA UDI	Class II	Active
ACURA Stabilization System 8.5 mm x 30 mm Polyaxial Screw	A004.0530	FDA UDI	Class II	Active
SEA-LINK Anterior Cervical Ø 4.5 mm L 10 mm Variable Angle Self Drilling Screw	A003.4510	FDA UDI	Class II	Active
ACURA Stabilization System	A004.2050	FDA UDI	Class II	Active
ACURA Stabilization System	A004.0440	FDA UDI	Class II	Active
ACURA Stabilization System	A004.2060	FDA UDI	Class II	Active
ACURA Stabilization System 7.5 mm x 30 mm Polyaxial Screw	A004.0430	FDA UDI	Class II	Active
ACURA Stabilization System	A004.3500	FDA UDI	Class II	Active
Ball Tip Probe	F008.0029	FDA UDI	Class I	Active
SEA-LINK Anterior Cervical Plate System	A003.0131	FDA UDI	Class II	Active
SEA-LINK Anterior Cervical Plate System	A003.0241	FDA UDI	Class II	Active
ACURA Stabilization System Ø 7.5 x 35 mm Polyaxial Screw - NT	A004.7435	FDA UDI	Class II	Active
ACURA Stabilization System 4.5 mm x 45 mm Polyaxial Screw	A004.0145	FDA UDI	Class II	Active
SEA-LINK Anterior Cervical Ø 4.0 mm L 20 mm Variable Angle Self Drilling Screw	A003.4420	FDA UDI	Class II	Active
Rod Pusher	F004.0005	FDA UDI	Class I	Active
SEA-LINK Anterior Cervical Plate System	A003.0366	FDA UDI	Class II	Active
ACURA Stabilization System Ø 7.5 x 55 mm Polyaxial Screw - NT	A004.7455	FDA UDI	Class II	Active
ACURA Stabilization System 8.5mm x 60mm Polyaxial Screw	A004.0560	FDA UDI	Class II	Active
ACURA Stabilization System - Torque limiting quick connect T handle (8 Nm)	IMDT.0015	FDA UDI	Class I	Active
Self – Retaining Driver T10	F003.0034	FDA UDI	Class I	Active
SEA-LINK Anterior Cervical Plate System	A003.0245	FDA UDI	Class II	Active
ACURA Stabilization System	A004.2125	FDA UDI	Class II	Active
ACURA Stabilization System	A004.0360	FDA UDI	Class II	Active
ACURA Stabilization System	A004.2080	FDA UDI	Class II	Active
SEA-LINK Anterior Cervical Plate System	A003.0254	FDA UDI	Class II	Active
ACURA Stabilization System - Torque Limiting Quick Connect T-handle (5.5 Nm)	IMDT.0034	FDA UDI	Class I	Active
ACURA Stabilization System Ø 9.5 x 55 mm Polyaxial Screw - NT	A004.7655	FDA UDI	Class II	Active
Drill Bit - 2.2 mm	F007.0032	FDA UDI	Class I	Active
ACURA Stabilization System - Flanged connector Driver	F004.0335	FDA UDI	Class I	Active
ACURA Stabilization System	A004.2055	FDA UDI	Class II	Active
SEA-LINK Anterior Cervical Plate System	A003.0127	FDA UDI	Class II	Active
Rotational Quick Connect Handle	IMDT.0032	FDA UDI	Class I	Active
ACURA Stabilization System 8.5 mm x 50 mm Polyaxial Screw	A004.0550	FDA UDI	Class II	Active
ACURA Stabilization System	A004.2045	FDA UDI	Class II	Active
ACURA Stabilization System - Cap Driver, Non Threaded	F004.0320	FDA UDI	Class I	Active
ACURA Stabilization System	A004.0125	FDA UDI	Class II	Active
Tapered Tap - 7.5 mm	F004.0375	FDA UDI	Class I	Active
ACURA Stabilization System 8.5 mm x 40 mm Polyaxial Screw	A004.0540	FDA UDI	Class II	Active
SEA-LINK Anterior Cervical Ø 4.0 mm L 16 mm Variable Angle Self Drilling Screw	A003.4416	FDA UDI	Class II	Active

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