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
SEA-LINK Anterior Cervical Ø 4.5 mm L 14 mm Variable Angle Self Drilling Screw	A003.4514	FDA UDI	Class II	Active
Bone Awl – Self Retracting	F003.0011	FDA UDI	Class I	Active
SEA-LINK Anterior Cervical Plate System	A003.0360	FDA UDI	Class II	Active
SEA-LINK Anterior Cervical Plate System	A003.0121	FDA UDI	Class II	Active
ACURA Stabilization System Ø 4.5 x 40 mm Polyaxial Screw - NT	A004.7140	FDA UDI	Class II	Active
ACURA Stabilization System	A004.2120	FDA UDI	Class II	Active
Self – Retaining Driver T10	F007.0018	FDA UDI	Class I	Active
ACURA Stabilization System	A004.2095	FDA UDI	Class II	Active
ACURA Stabilization System Ø 5.5 x 40 mm Cannulated Polyaxial Screw - NT	A005.7240	FDA UDI	Class II	Active
ACURA Stabilization System - Flanged Connector Guide	F004.0052	FDA UDI	Class I	Active
ACURA Stabilization System Ø 7.5 x 45 mm Polyaxial Screw - NT	A004.7445	FDA UDI	Class II	Active
ACURA Stabilization System - Ball Tip Probe	F004.0119	FDA UDI	Class I	Active
ACURA Stabilization System - Curved Lenke Probe	F004.0113	FDA UDI	Class I	Active
ACURA Stabilization System 7.5 mm x 60 mm Polyaxial Screw	A004.0460	FDA UDI	Class II	Active
Self – Retaining Driver T20	F004.0334	FDA UDI	Class I	Active
ACURA Stabilization System	A004.0250	FDA UDI	Class II	Active
Tapered Tap - 8.5 mm	F004.0385	FDA UDI	Class I	Active
Plate Bender	F003.0003	FDA UDI	Class I	Active
SEA-LINK Anterior Cervical Plate System	A003.0477	FDA UDI	Class II	Active
ACURA Stabilization System 8.5 mm x 35 mm Polyaxial Screw	A004.0535	FDA UDI	Class II	Active
ACURA Stabilization System	A004.0455	FDA UDI	Class II	Active
ACURA Stabilization System Ø 9.5 x 40 mm Polyaxial Screw - NT	A004.7640	FDA UDI	Class II	Active
ACURA Stabilization System	A004.0130	FDA UDI	Class II	Active
ACURA Stabilization System	A004.0330	FDA UDI	Class II	Active
ACURA Stabilization System Ø 7.5 x 20 mm Polyaxial Screw	A004.0420	FDA UDI	Class II	Active
ACURA Stabilization System Ø 5.5 x 35 mm Cannulated Polyaxial Screw - NT	A004.7235	FDA UDI	Class II	Active
ACURA Stabilization System	A004.0435	FDA UDI	Class II	Active
ACURA Stabilization System Ø 8.5 x 55 mm Polyaxial Screw - NT	A004.7555	FDA UDI	Class II	Active
SEA-LINK Anterior Cervical Plate System	A003.0473	FDA UDI	Class II	Active
Tapered Awl	F004.0067	FDA UDI	Class I	Active
ACURA Stabilization System	A004.2035	FDA UDI	Class II	Active
ACURA Stabilization System	A004.0235	FDA UDI	Class II	Active
Parallel Compressor	F004.0047	FDA UDI	Class I	Active
ACURA Stabilization System Ø 10.5 x 40 mm Polyaxial Screw - NT	A004.7740	FDA UDI	Class II	Active
ACURA Stabilization System - Ratcheting quick connect T handle	IMDT.0014	FDA UDI	Class I	Active
Parallel Distractor	F004.0048	FDA UDI	Class I	Active
ACURA Stabilization System Ø 5.5 x 50 mm Cannulated Polyaxial Screw - NT	A004.7250	FDA UDI	Class II	Active
ACURA Stabilization System - Final Tightening Driver, Long	F004.0322	FDA UDI	Class I	Active
Drill Guide	F003.0032	FDA UDI	Class I	Active
SEA-LINK Anterior Cervical Ø 4.5 mm L 16 mm Variable Angle Self Drilling Screw	A003.4516	FDA UDI	Class II	Active
ACURA Stabilization System - Counter Torque NT	F004.0053	FDA UDI	Class I	Active
ACURA Stabilization System - Cap Driver	F004.0316	FDA UDI	Class I	Active
Bone Drill	F003.0001	FDA UDI	Class I	Active
ACURA Stabilization System - Rod Holder (Small)	F004.0029	FDA UDI	Class I	Active
ACURA Stabilization System Non-Threaded Locking Cap	A004.4001	FDA UDI	Class II	Active
ACURA Stabilization System Ø 6.5 x 45 mm Polyaxial Screw - NT	A004.7345	FDA UDI	Class II	Active
ACURA Stabilization System	A004.2070	FDA UDI	Class II	Active
SEA-LINK Anterior Cervical Plate System	A003.0233	FDA UDI	Class II	Active
ACURA Stabilization System - Tower Reducer NT	F004.0055	FDA UDI	Class I	Active
ACURA Stabilization System Ø 6.5 x 60 mm Polyaxial Screw - NT	A004.7360	FDA UDI	Class II	Active

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