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 5.5 x 45 mm Cannulated Polyaxial Screw - NT	A005.7245	FDA UDI	Class II	Active
Final Tightening Driver, Short	F004.0308	FDA UDI	Class I	Active
Vice Grip	F004.0050	FDA UDI	Class I	Active
ACURA Stabilization System Ø 8.5 x 45 mm Polyaxial Screw - NT	A004.7545	FDA UDI	Class II	Active
ACURA Stabilization System - Rigid Screw Driver, SNAP ON (NT)	F004.0327	FDA UDI	Class I	Active
SEA-LINK Anterior Cervical Plate System	A003.0248	FDA UDI	Class II	Active
SEA-LINK Anterior Cervical Plate System	A003.0363	FDA UDI	Class II	Active
Tapered Tap - 6.5 mm	F004.0365	FDA UDI	Class I	Active
ACURA Stabilization System	F004.0332	FDA UDI	Class I	Active
ACURA Stabilization System	A004.2150	FDA UDI	Class II	Active
ACURA Stabilization System - Tower Reducer	F004.0013	FDA UDI	Class I	Active
ACURA Stabilization System	A004.2040	FDA UDI	Class II	Active
ACURA Stabilization System	A004.2065	FDA UDI	Class II	Active
ACURA Stabilization System	A004.0240	FDA UDI	Class II	Active
SEA-LINK Anterior Cervical Plate System	A003.0357	FDA UDI	Class II	Active
SEA-LINK Anterior Cervical Ø 4.5 mm L 18 mm Variable Angle Self Drilling Screw	A003.4518	FDA UDI	Class II	Active
ACURA Stabilization System Ø 8.5 x 40 mm Polyaxial Screw - NT	A004.7540	FDA UDI	Class II	Active
ACURA Stabilization System -Cross Connector , 38-48 mm	A004.3848	FDA UDI	Class II	Active
ACURA Stabilization System Ø 9.5 x 45 mm Polyaxial Screw - NT	A004.7645	FDA UDI	Class II	Active
ACURA Stabilization System - Rigid Screw Driver (NT)	F004.0319	FDA UDI	Class I	Active
2.5 mm Hex Driver Assembly	F003.0005	FDA UDI	Class I	Active
ACURA Stabilization System	A004.2090	FDA UDI	Class II	Active
ACURA Stabilization System	A004.0040	FDA UDI	Class II	Active
Anti-Splay Flanged Connector	A004.4001	FDA UDI	Class II	Active
ACURA Stabilization System - Ratcheting quick connect Straight handle	IMDT.0039	FDA UDI	Class I	Active
ACURA Stabilization System - Final Tightening Driver-NT	F004.0330	FDA UDI	Class I	Active
ACURA Stabilization System Ø 4.5 x 45 mm Polyaxial Screw - NT	A004.7145	FDA UDI	Class II	Active
ACURA Stabilization System Ø 4.5 x 35 mm Polyaxial Screw - NT	A004.7135	FDA UDI	Class II	Active
SEA-LINK Anterior Cervical Plate System	A003.0497	FDA UDI	Class II	Active
ACURA Stabilization System	A004.0335	FDA UDI	Class II	Active
Tapered Tap - 5.5 mm	F004.0355	FDA UDI	Class I	Active
ACURA Stabilization System	A004.3075	FDA UDI	Class II	Active
Driver with Sleeve	F003.0018	FDA UDI	Class I	Active
Temporary Fixation Pin	F003.0014	FDA UDI	Class II	Active
ACURA Stabilization System Ø 7.5 x 50 mm Polyaxial Screw - NT	A004.7450	FDA UDI	Class II	Active
Screw Head Positioner	F004.0002	FDA UDI	Class I	Active
SEA-LINK Anterior Cervical Plate System	A003.0251	FDA UDI	Class II	Active
ACURA Stabilization System	A004.0445	FDA UDI	Class II	Active
ACURA Stabilization System	A004.0140	FDA UDI	Class II	Active
ACURA Stabilization System Ø 8.5 x 35 mm Polyaxial Screw - NT	A004.7535	FDA UDI	Class II	Active
ACURA Stabilization System 8.5 mm x 45 mm Polyaxial Screw	A004.0545	FDA UDI	Class II	Active
Solid Torx Screw Driver, T10	F003.0027	FDA UDI	Class I	Active
ACURA Stabilization System Ø 8.5 x 50 mm Polyaxial Screw - NT	A004.7550	FDA UDI	Class II	Active
Paddle Distractor	F015.0006	FDA UDI	Class I	Active
Rod Template	F004.0006	FDA UDI	Class I	Active
ACURA Stabilization System	A004.2110	FDA UDI	Class II	Active
ACURA Stabilization System Ø 10.5 x 50 mm Polyaxial Screw - NT	A004.7750	FDA UDI	Class II	Active
SEA-LINK Anterior Cervical Plate System	A003.0469	FDA UDI	Class II	Active
SEA-LINK Anterior Cervical Ø 4.5 mm L 12 mm Variable Angle Self Drilling Screw	A003.4512	FDA UDI	Class II	Active
SEA-LINK Anterior Cervical Ø 4.5 mm L 20 mm Variable Angle Self Drilling Screw	A003.4520	FDA UDI	Class II	Active

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