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
2.4mm Wise-Lock Screws, Self Tapping, Length 14 mm	TI-M17.14	FDA UDI	Class II	Active
2.4mm Wise-Lock Screws, Self Tapping, Length 8 mm	TI-M17.08	FDA UDI	Class II	Active
2.4 mm Variable Angle Volar Rim Distal Radius Plate, 6 Head Holes (Right), 5 hole	Ti-560-06-05R	FDA UDI	Class II	Active
4.5/5.0mm Wise-Lock Narrow Dynamic Compression Plate with LC under cuts, 24 Holes	723.224	FDA UDI	Class II	Active
2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Narrow (Left), 6 head	Ti-546.007L	FDA UDI	Class II	Active
2.4 mm Wise lock Screw, Self tapping, Star Head, 16mm length	Ti-1145.16	FDA UDI	Class II	Active
3.5mm Wise-Lock Medial Distal Tibia Plate, 8 Holes - Left	TI-746.108L	FDA UDI	Class II	Active
AJAX Nail	TI-6085S-11-170	FDA UDI	Class II	Active
Retrograde Femoral Nail	TI-1458-12-200	FDA UDI	Class II	Active
2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Wide (Left), 7 head H	Ti-548.007R	FDA UDI	Class II	Active
Ga-mma Nail	TI-600-085	FDA UDI	Class II	Active
2.4mm Wise-Lock Volar Column Distal Radius Plate, Right (9 Head Holes), 3 holes	Ti-M759.203RS	FDA UDI	Class II	Active
2.4mm Wise-Lock Screws, Self Tapping, Length 22 mm	TI-M17.22	FDA UDI	Class II	Active
3.5mm Wise-Lock Screws, Self Tapping, Length 20 mm	TI-117.020	FDA UDI	Class II	Active
Auxein Brand Vertaux 5.5 mm Pedicle Screw System	SP-237	FDA UDI	Class II	Active
AJAX Nail	TI-6086L-10-260L	FDA UDI	Class II	Active
4.5/5.0mm Wise-Lock Broad Dynamic Compression Plate with LC under cuts, 16 Holes	TI-725.216	FDA UDI	Class II	Active
2.4 mm Cortical Screw, Self-tapping, Star Head, 10mm length	Ti-1242.10S	FDA UDI	Class II	Active
5.0mm Wise-Lock Screws, Self Tapping, Length 32 mm	119.032	FDA UDI	Class II	Active
Auxein Brand Vertaux 5.5 mm Pedicle Screw System	SP-232	FDA UDI	Class II	Active
AJAX Nail	TI-6085L-12-260L	FDA UDI	Class II	Active
AJAX Nail	TI-6085-01-068	FDA UDI	Class II	Active
Titanium Elastic Nail	412-3.0-044	FDA UDI	Class II	Active
2.4 mm Cortical Screw, Self-tapping, Hex Head, 12mm length	Ti-M18.12S	FDA UDI	Class II	Active
Humeral Nail	TI-1221.060	FDA UDI	Class II	Active
AJAX Nail	TI-6086L-11-420L	FDA UDI	Class II	Active
4.5/5.0mm Wise-Lock Proximal Femoral Plate, 8 Holes - Right	TI-798.008R	FDA UDI	Class II	Active
3.5mm Wise-Lock Clavicle Hook Plate, Hook Depth 15 mm, 6 Holes - Left	452.6.15L	FDA UDI	Class II	Active
4.5/5.0mm Wise-Lock Broad Dynamic Compression Plate with LC under cuts, 18 Holes	725.218	FDA UDI	Class II	Active
2.7mm Wise-Lock Screws, Self Tapping, Length 28 mm	TI-118.028	FDA UDI	Class II	Active
2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Standard (Right), 6 h	Ti-546.206RS	FDA UDI	Class II	Active
2.4mm Variable Angle Two-Column Volar Distal Radius Plate, Wide (Left), 7 head H	Ti-548.207RS	FDA UDI	Class II	Active
Expert Tibia Nail	TI-520-10-255	FDA UDI	Class II	Active
5.0 mm Wise-Lock Screws, Self Tapping & Self Drilling, Length 26 mm	119.226	FDA UDI	Class II	Active
2.7mm Cortical Screw, Self-Tapping, (Star Head), 12mm length	Ti-1242.12S	FDA UDI	Class II	Active
Auxein Brand Vertaux 5.5 mm Pedicle Screw System	SP-1649	FDA UDI	Class II	Active
Auxein Brand Vertaux 5.5 mm Pedicle Screw System	SP-333	FDA UDI	Class II	Active
130° Ga-mma Nail	TI-1457L-13-420R	FDA UDI	Class II	Active
4.5/5.0mm Wise-Lock "T" Plate, 4 Holes	TI-709.204	FDA UDI	Class II	Active
AJAX Nail	TI-6086L-11-420R	FDA UDI	Class II	Active
3.5mm Wise-Lock Screws, Self Tapping, Length 28 mm	TI-117.028	FDA UDI	Class II	Active
3.5mm Wise-Lock Screws, Self Tapping, Length 20 mm	117.020	FDA UDI	Class II	Active
Expert Tibia Nail	TI-520-001-10	FDA UDI	Class II	Active
3.5mm Wise-Lock Screws, Self Drilling, Length 32 mm	TI-117.232	FDA UDI	Class II	Active
AJAX Nail	TI-6086L-10-420R	FDA UDI	Class II	Active
130° Ga-mma Nail	TI-1457L-09-360R	FDA UDI	Class II	Active
4.5/5.0mm Wise-Lock Proximal Lateral Tibial Plate, 11 Holes - Left	733.211L	FDA UDI	Class II	Active
Auxilock Titanium Interference Screw	6-010-17	FDA UDI	Class II	Active
3.5mm Wise-Lock Anterolateral Distal Tibia Plate, 17 Holes - Left	TI-WS1.17	FDA UDI	Class II	Active
2.7mm Wise-Lock Screws, Self Tapping, Length 24 mm	118.024	FDA UDI	Class II	Active

Auxein Medical Private Limited

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