Question 1

What types of devices does Miami Device Solutions manufacture?

Accepted Answer

Miami Device Solutions manufactures orthopaedic fixation devices including non-bioabsorbable plates and bone screws, internal fixation systems combining plates and screws, and reusable surgical instruments such as drill guides, depth gauges, aiming blocks, and implant inserters/extractors. The company also produces instrument transport trolleys and related hardware like plate holders and torque limiter handles.

All devices are classified as Class II and are listed in the FDA's Unique Device Identification (FDA UDI) system. The company is based in the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Question 2

Where is Miami Device Solutions based?

Accepted Answer

Miami Device Solutions is based in the United States, as explicitly stated in the device data under the COUNTRY field, which specifies US as the country of origin for the manufacturer.

Question 3

Which regulatory registries list the devices made by Miami Device Solutions?

Accepted Answer

The devices manufactured by Miami Device Solutions are listed in the FDA's Unique Device Identification (FDA UDI) system, as indicated in the LISTED IN field of the device data, which specifies fda_udi as the registry where their devices are registered.

Question 4

How are the devices made by Miami Device Solutions classified?

Accepted Answer

All devices produced by Miami Device Solutions are classified as Class II, as stated in the DEVICE CLASSES field of the device data, which uniformly assigns Class II to every device category and example listed.

Device	Model / Reference	Registries	Class	Status
Cerclage Button Caddy	MDS111210	FDA UDI	Class II	Active
Multiuse Screw, 3.5mm	MDS1102M51	FDA UDI	Class II	Active
Distal Radius Plate	MDS1401S03LA	FDA UDI	Class II	Active
Distal Radius Plate	MDS1401N04L	FDA UDI	Class II	Active
Disassembly Tool for Polyaxial Drill Guide	MDS110808	FDA UDI	Class II	Active
Locking Cap Block, Right	MDS130902R	FDA UDI	Class II	Active
Cortical Screw, 2.0mm	MDS1902X30	FDA UDI	Class II	Active
Low Profile Head Screw, 2.7mm	MDS1002CO26	FDA UDI	Class II	Active
Distal Humerus Plate, Medial	MDS170107M	FDA UDI	Class II	Active
Cortical Screw, 2.7mm	MDS1002X56	FDA UDI	Class II	Active
Countersink for 2.7mm Low Profile Head Screw	MDS110826VAO	FDA UDI	Class II	Active
Distal Radius Plate	MDS1401S04LA	FDA UDI	Class II	Active
Cortical Screw, 2.7mm	MDS1002X44	FDA UDI	Class II	Active
Olecranon Plating System Screw Caddy	MDS161206	FDA UDI	Class II	Active
Cannulated Screw	K161058	FDA 510(k)	Class II	Active
Olecranon Plating System	K162898	FDA 510(k)	Class II	Active
Distal Radius Plating System	K182810	FDA 510(k)	Class II	Active
MDS Plating System	K172786	FDA 510(k)	Class II	Active
Distal Radius Plating System	K162635	FDA 510(k)	Class II	Active
Distal Radius Plating System	K161292	FDA 510(k)	Class II	Active
Proximal Humerus Plating System	K141493	FDA 510(k)	Class II	Active

Miami Device Solutions

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