Question 1

What types of medical devices does Auxein Medical Private Limited manufacture?

Accepted Answer

Auxein Medical Private Limited specializes in orthopaedic fixation devices. Their product range includes non-sliding bone screws, non-bioabsorbable fixation plates for stabilizing long bones, intramedullary nails for the femur, tibia, and humerus, and internal spinal fixation systems with bone screws. They also produce bone nail end-caps, tendon/ligament anchors, and specialized plates like the Wise-Lock series and Gamma Nail for targeted orthopaedic applications.

Question 2

Where is Auxein Medical Private Limited based?

Accepted Answer

Auxein Medical Private Limited is headquartered in the United States. The company’s location is relevant for regulatory oversight, manufacturing compliance, and distribution logistics, particularly for devices authorized in the U.S. market.

Question 3

Which regulatory registries list Auxein Medical’s devices?

Accepted Answer

Auxein Medical’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency for authorized orthopaedic fixation products, including intramedullary nails, plates, and screws, under the U.S. regulatory framework.

Question 4

How are Auxein Medical’s devices classified under FDA regulations?

Accepted Answer

Auxein Medical’s devices fall under Class II classification by the FDA. This classification applies to products that pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure safety and effectiveness. Examples include intramedullary nails, fixation plates, and bone anchors, which require validation for proper use in orthopaedic procedures.

Question 5

Why are Auxein Medical’s devices listed as Class II?

Accepted Answer

The Class II designation for Auxein Medical’s devices reflects their role in stabilizing fractures and supporting bone healing, which carries inherent risks like improper placement or material failure. The FDA mandates Class II for such products to balance regulatory oversight with innovation, ensuring devices meet performance criteria (e.g., mechanical strength, biocompatibility) while allowing continuous improvement in design and materials.

Device	Model / Reference	Registries	Class	Status
2.4 mm Cortical Screw, Self-tapping, Star Head, 6mm length	Ti-1244.06S	FDA UDI	Class II	Active
Ga-mma Nail	TI-1457-010E	FDA UDI	Class II	Active
3.5mm Wise-Lock Anterolateral Distal Tibia Plate, 11 Holes - Left	WS1.11	FDA UDI	Class II	Active
130° Ga-mma Nail	TI-1457L-10-320R	FDA UDI	Class II	Active
2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Wide (Left), 7 head H	Ti-548.008R	FDA UDI	Class II	Active
4.5/5.0mm Wise-Lock Distal Femur Plate, 6 Holes - Right	TI-748.106R	FDA UDI	Class II	Active
2.4mm Wise-Lock Volar Column Distal Radius Plate, Right (8 Head Holes), 4 holes	Ti-759.104R	FDA UDI	Class II	Active
3.5mm Wise-Lock Small "T" Plate, Oblique Angled, 6 Holes - Left	TI-712.106L	FDA UDI	Class II	Active
4.5/5.0mm Wise-Lock Reconstruction Plate, 11 Holes	728.211	FDA UDI	Class II	Active
Expert Femoral Nail	TI-1458-4.8-042	FDA UDI	Class II	Active
2.4mm Wise-Lock"L'' Distal Radius Dorsal Plate, (3 Head Holes), Left, 3 holes	Ti-M04.03S	FDA UDI	Class II	Active
2.4mm Wise-Lock "L'' Distal Radius Dorsal Plate, Oblique, left, 4 holes	Ti-M06.04S	FDA UDI	Class II	Active
Expert Femoral Nail	TI-1459-12-360L	FDA UDI	Class II	Active
Expert Tibia Nail	TI-520-10-270	FDA UDI	Class II	Active
2.4mm Wise-Lock Proximal Radius Plate for Radius Head Rim, Right, 3 holes	Ti-M544.003RS	FDA UDI	Class II	Active
3.5mm Wise-Lock Screws, Self Tapping, Length 32 mm	TI-117.032	FDA UDI	Class II	Active
3.5mm Wise-Lock Screws, Self Tapping, Length 24 mm	117.024	FDA UDI	Class II	Active
Expert Femoral Nail	TI-1459-13-380R	FDA UDI	Class II	Active
3.5mm Wise-Lock Screws, Self Drilling, Length 60 mm	117.260	FDA UDI	Class II	Active
AJAX Nail	TI-6085-01-076	FDA UDI	Class II	Active
Expert Tibia Nail	TI-520-058-76	FDA UDI	Class II	Active
5.0 mm Wise-Lock Screws, Self Tapping & Self Drilling, Length 48 mm	119.248	FDA UDI	Class II	Active
2.4mm Wise-Lock Proximal Radius Plate for Radius Head Rim, Right, 2 holes	Ti-M544.002RS	FDA UDI	Class II	Active
Expert Tibia Nail	TI-520-11-255	FDA UDI	Class II	Active
2.4mm Wise-Lock Distal Radius Volar Plate, Extra-articular, ( 4 Head Holes), Lef	Ti-M12.03	FDA UDI	Class II	Active
Auxein Brand Vertaux 5.5 mm Pedicle Screw System	SP-344	FDA UDI	Class II	Active
2.4 mm Cortical Screw, Self-tapping, Hex Head, 6mm length	Ti-M18.06S	FDA UDI	Class II	Active
4.5/5.0mm Wise-Lock Narrow Dynamic Compression Plate with LC under cuts, 11 Holes	723.211	FDA UDI	Class II	Active
2.4 mm Cortical Screw, Self-tapping, Hex Head, 20mm length	Ti-M18.20S	FDA UDI	Class II	Active
4.5/5.0mm Wise-Lock Broad Dynamic Compression Plate with LC under cuts, 9 Holes	725.209	FDA UDI	Class II	Active
AJAX Nail	TI-6085L-11-420L	FDA UDI	Class II	Active
5.0 mm Wise-Lock Screws, Self Tapping & Self Drilling, Length 30 mm	TI-119.230	FDA UDI	Class II	Active
2.4 mm Wise lock Screw, Self tapping, Star Head, 30mm length	Ti-1145.30	FDA UDI	Class II	Active
Auxein Brand Vertaux 5.5 mm Pedicle Screw System	SP-310	FDA UDI	Class II	Active
3.5mm Wise-Lock Clavicle Hook Plate, Hook Depth 12 mm, 6 Holes - Left	452.6.12L	FDA UDI	Class II	Active
3.5mm Wise-Lock Screws, Self Drilling, Length 48 mm	TI-117.248	FDA UDI	Class II	Active
AJAX Nail	TI-6086L-09-260L	FDA UDI	Class II	Active
Expert Tibia Nail	TI-520-058-32	FDA UDI	Class II	Active
3.5mm Wise-Lock Anterolateral Distal Tibia Plate, 9 Holes - Right	WS2.09	FDA UDI	Class II	Active
4.5/5.0mm Wise-Lock Proximal Femoral Plate, 2 Holes - Left	TI-798.002L	FDA UDI	Class II	Active
Auxein Brand Vertaux 5.5 mm Pedicle Screw System	SP-332	FDA UDI	Class II	Active
3.5mm Wise-Lock Small "T" Plate, Oblique Angled, 4 Holes - Right	712.104R	FDA UDI	Class II	Active
Expert Femoral Nail	TI-1459-130	FDA UDI	Class II	Active
2.4mm Wise-Lock “T” Distal Radius Dorsal Plate, (3 Head Holes), 3 Holes	TI-M08.03	FDA UDI	Class II	Active
2.4mm Wise-Lock Volar Buttress Plate Right (5 Head Holes), Right, 3 holes	Ti-M11.03R	FDA UDI	Class II	Active
130° Ga-mma Nail	TI-1457L-11-420R	FDA UDI	Class II	Active
Ga-mma Nail	TI-600A-6.4-090	FDA UDI	Class II	Active
Humeral Nail	TI-1222.035	FDA UDI	Class II	Active
3.5mm Wise-Lock Screws, Self Drilling, Length 60 mm	TI-117.260	FDA UDI	Class II	Active
3.5mm Wise-Lock Anterolateral Distal Tibia Plate, 19 Holes - Right	WS2.19	FDA UDI	Class II	Active

Auxein Medical Private Limited

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