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
2.7 mm Cortical screw, self-tapping, Hex Head, 24mm length	Ti-103.224S	FDA UDI	Class II	Active
4.5/5.0mm Wise-Lock "T" Plate, 6 Holes	709.206	FDA UDI	Class II	Active
Expert Femoral Nail	TI-1458-4.8-058	FDA UDI	Class II	Active
3.5mm Wise-Lock Screws, Self Drilling, Length 12 mm	117.212	FDA UDI	Class II	Active
130° Ga-mma Nail	TI-1457L-11-380R	FDA UDI	Class II	Active
4.5/5.0mm Wise-Lock Distal Femur Plate, 13 Holes - Right	TI-748.113R	FDA UDI	Class II	Active
4.5/5.0mm Wise-Lock Narrow Dynamic Compression Plate with LC under cuts, 9 Holes	TI-723.209	FDA UDI	Class II	Active
AJAX Nail	TI-6086L-11-300L	FDA UDI	Class II	Active
AJAX Nail	TI-6086L-9-400R	FDA UDI	Class II	Active
130° Ga-mma Nail	TI-1457L-11-440L	FDA UDI	Class II	Active
Auxein Brand Vertaux 5.5 mm Pedicle Screw System	SP-1662	FDA UDI	Class II	Active
2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Narrow (Left), 6 head	Ti-M546.008LS	FDA UDI	Class II	Active
4.5/5.0mm Wise-Lock Proximal Femoral Plate, 8 Holes - Right	798.008R	FDA UDI	Class II	Active
3.5mm Wise-Lock Proximal Tibia Plate, 12 Holes - Left	TI-747.112L	FDA UDI	Class II	Active
Auxein Brand Vertaux 5.5 mm Pedicle Screw System	SP-1661	FDA UDI	Class II	Active
Auxein Brand Vertaux 5.5 mm Pedicle Screw System	SP-251	FDA UDI	Class II	Active
2.4 mm Variable Angle Volar Rim Distal Radius Plate, 6 Head Holes (Left), 4 holes	Ti-560-06-04LS	FDA UDI	Class II	Active
2.4mm Wise-Lock Distal Radius Volar Plate, Extra-articular, ( 4 Head Holes), Rig	Ti-M13.03S	FDA UDI	Class II	Active
3.5mm Wise-Lock Anterolateral Distal Tibia Plate, 11 Holes - Left	TI-WS1.11	FDA UDI	Class II	Active
4.5/5.0mm Wise-Lock Proximal Femoral Plate, 8 Holes - Left	798.008L	FDA UDI	Class II	Active
Expert Femoral Nail	TI-1459-9-360L	FDA UDI	Class II	Active
Ga-mma Nail	TI-1457-015E	FDA UDI	Class II	Active
3.5mm Wise-Lock Screws, Self Tapping, Length 48 mm	TI-117.048	FDA UDI	Class II	Active
3.5mm Wise-Lock Screws, Self Drilling, Length 10 mm	117.210	FDA UDI	Class II	Active
2.4 mm Wise-Lock Screw, Self-tapping, Hex head, 16mm length	Ti-M17.16S	FDA UDI	Class II	Active
Humeral Nail	TI-6001.024	FDA UDI	Class II	Active
5.0 mm Wise-Lock Screws, Self Tapping & Self Drilling, Length 26 mm	TI-119.226	FDA UDI	Class II	Active
5.0 mm Wise-Lock Screws, Self Tapping & Self Drilling, Length 24 mm	TI-119.224	FDA UDI	Class II	Active
2.7mm Wise-Lock Screws, Self Tapping, Length 60 mm	TI-118.060	FDA UDI	Class II	Active
Humeral Nail	Tl-6084.00	FDA UDI	Class II	Active
2.4 mm Variable Angle Volar Rim Distal Radius Plate, 7 Head Holes (Right), 5 hole	Ti-560-07-05RS	FDA UDI	Class II	Active
4.5/5.0mm Wise-Lock Proximal Lateral Tibial Plate, 9 Holes - Left	TI-733.209L	FDA UDI	Class II	Active
3.5mm Wise-Lock Clavicle Hook Plate, Hook Depth 18mm, 4 Holes - Right	452.4.18R	FDA UDI	Class II	Active
Retrograde Femoral Nail	TI-1458-076	FDA UDI	Class II	Active
AJAX Nail	TI-6086L-9-360R	FDA UDI	Class II	Active
2.4 mm Cortical Screw, Self-tapping, Hex Head, 30mm length	Ti-M18.30	FDA UDI	Class II	Active
3.5mm Wise-Lock Anterolateral Distal Tibia Plate, 17 Holes - Right	TI-WS2.17	FDA UDI	Class II	Active
Expert Femoral Nail	TI-1459-13-440L	FDA UDI	Class II	Active
3.5mm Wise-Lock Screws, Self Drilling, Length 54 mm	117.254	FDA UDI	Class II	Active
3.5mm Wise-Lock Medial Distal Tibia Plate, 4 Holes - Right	TI-746.104R	FDA UDI	Class II	Active
Auxein Brand Vertaux 5.5 mm Pedicle Screw System	SP-212	FDA UDI	Class II	Active
3.5mm Wise-Lock Anterolateral Distal Tibia Plate, 5 Holes - Left	WS1.05	FDA UDI	Class II	Active
5.0mm Wise-Lock Screws, Self Tapping, Length 40 mm	119.040	FDA UDI	Class II	Active
Ga-mma Nail	TI-600-036	FDA UDI	Class II	Active
2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Wide (Left), 7 head H	Ti-548.206RS	FDA UDI	Class II	Active
Auxein Brand Vertaux 5.5 mm Pedicle Screw System	SP-227	FDA UDI	Class II	Active
3.5mm Wise-Lock Medial Distal Tibia Plate, 14 Holes - Left	TI-746.114L	FDA UDI	Class II	Active
2.4mm Wise-Lock"L'' Distal Radius Dorsal Plate, (2 Head Holes), Right, 4 holes	TI-M03.04	FDA UDI	Class II	Active
3.5mm Wise-Lock Screws, Self Drilling, Length 18 mm	117.218	FDA UDI	Class II	Active
Expert Femoral Nail	TI-1458-4.8-054	FDA UDI	Class II	Active

Auxein Medical Private Limited

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