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
AJAX Nail	TI-6086S-09-170	FDA UDI	Class II	Active
Humeral Nail	TI-6082-9.0-180	FDA UDI	Class II	Active
AJAX Nail	TI-6085-06-115	FDA UDI	Class II	Active
4.5/5.0mm Wise-Lock Broad Dynamic Compression Plate with LC under cuts, 13 Holes	TI-725.213	FDA UDI	Class II	Active
4.5/5.0mm Wise-Lock Proximal Lateral Tibial Plate, 9 Holes - Right	733.209R	FDA UDI	Class II	Active
130° Ga-mma Nail	TI-1457L-10-380L	FDA UDI	Class II	Active
AJAX Nail	TI-6086L-10-260R	FDA UDI	Class II	Active
2.4mm Wise-Lock Volar Column Distal Radius Plate, Left (8 Head Holes), 5 holes	Ti-M759.105LS	FDA UDI	Class II	Active
2.4mm Wise-Lock Volar Buttress Plate, left ( 5 Head Holes), Right, 3 holes	Ti-M11.03LS	FDA UDI	Class II	Active
2.4mm Variable Angle Screw, Self Tapping, Star head, 10mm length	Ti-549.010S	FDA UDI	Class II	Active
Expert Femoral Nail	TI-1459-11-340L	FDA UDI	Class II	Active
AJAX Nail	TI-6085-01-074	FDA UDI	Class II	Active
2.4mm Wise-Lock Proximal Radius Plate for Radius Head Rim, Left, 4 holes	Ti-544.004L	FDA UDI	Class II	Active
Expert Femoral Nail	TI-1459-13-420R	FDA UDI	Class II	Active
3.5mm Wise-Lock Medial Distal Tibia Plate, 10 Holes - Right	TI-746.110R	FDA UDI	Class II	Active
2.4 mm Wise-Lock Screw, Self-tapping, Hex head, 10mm length	Ti-M17.10S	FDA UDI	Class II	Active
Auxein Brand Vertaux 5.5 mm Pedicle Screw System	SP-209	FDA UDI	Class II	Active
3.5mm Wise-Lock Medial Distal Tibia Plate, 14 Holes - Right	746.114R	FDA UDI	Class II	Active
2.4mm Wise-Lock"L'' Distal Radius Dorsal Plate, (3 Head Holes), Left, 4 holes	Ti-M04.04	FDA UDI	Class II	Active
3.5mm Wise-Lock Clavicle Hook Plate, Hook Depth 12mm, 7 Holes - Right	TI-452.7.12R	FDA UDI	Class II	Active
5.0mm Wise-Lock Screws, Self Tapping, Length 75 mm	TI-119.075	FDA UDI	Class II	Active
2.4 mm Wise lock Screw, Self tapping, Star Head, 6mm length	Ti-1145.06	FDA UDI	Class II	Active
AJAX Nail	TI-6085L-10-400L	FDA UDI	Class II	Active
AJAX Nail	TI-6086L-12-380R	FDA UDI	Class II	Active
AJAX Nail	TI-6085L-11-420R	FDA UDI	Class II	Active
AJAX Nail	TI-6085L-11-320L	FDA UDI	Class II	Active
Humeral Nail	TI-6082-8.0-240	FDA UDI	Class II	Active
Expert Femoral Nail	TI-1459-070	FDA UDI	Class II	Active
2.4mm Variable Angle Screw, Self-Tapping, Star head, 28mm length	Ti-549.028	FDA UDI	Class II	Active
2.7mm Wise-Lock Screws, Self Tapping, Length 56 mm	118.056	FDA UDI	Class II	Active
Auxein Brand Vertaux 5.5 mm Pedicle Screw System	SP-347	FDA UDI	Class II	Active
2.4mm Wise-Lock Proximal Radius Plate for Radius Head Rim, Right, 2 holes	Ti-544.002R	FDA UDI	Class II	Active
3.5mm Wise-Lock Small Dynamic Compression Plate with LC under cuts, 5 Holes	721.205	FDA UDI	Class II	Active
2.4 mm Cortical Screw, Self-tapping, Star Head, 14mm length	Ti-1242.14S	FDA UDI	Class II	Active
3.5mm Wise-Lock Clavicle Hook Plate, Hook Depth 12mm, 4 Holes - Left	452.4.12L	FDA UDI	Class II	Active
Expert Tibia Nail	TI-520-002-65	FDA UDI	Class II	Active
Auxein Brand Vertaux 5.5 mm Pedicle Screw System	SP-904	FDA UDI	Class II	Active
Expert Tibia Nail	TI-520-002-80	FDA UDI	Class II	Active
2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 h	Ti-546.205R	FDA UDI	Class II	Active
4.5/5.0mm Wise-Lock "T" Plate, 5 Holes	TI-709.205	FDA UDI	Class II	Active
3.5mm Wise-Lock Screws, Self Tapping, Length 16 mm	117.016	FDA UDI	Class II	Active
Humeral Nail	TI-1222.055	FDA UDI	Class II	Active
5.0mm Wise-Lock Screws, Self Tapping, Length 26 mm	TI-119.026	FDA UDI	Class II	Active
2.4 mm Cortical Screw, Self-tapping, Hex Head, 14mm length	Ti-M18.14S	FDA UDI	Class II	Active
3.5mm Wise-Lock Screws, Self Tapping, Length 56 mm	TI-117.056	FDA UDI	Class II	Active
3.5mm Wise-Lock Clavicle Hook Plate, Hook Depth 18mm, 6 Holes - Right	TI-452.6.18R	FDA UDI	Class II	Active
130° Ga-mma Nail	TI-1457L-10-400R	FDA UDI	Class II	Active
Auxilock Titanium Interference Screw	6-010-21	FDA UDI	Class II	Active
Ga-mma Nail	TI-1457-001E	FDA UDI	Class II	Active
130° Ga-mma Nail	TI-1457L-13-360L	FDA UDI	Class II	Active

Auxein Medical Private Limited

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