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SKELETAL DYNAMICS L.L.C.

Last updated May 24, 2026

What SKELETAL DYNAMICS L.L.C. makes

Skeletal Dynamics LLC manufactures orthopaedic fixation devices, including non-sliding bone screws and non-bioabsorbable plating systems for elbow and humeral applications. Their portfolio also includes elbow and metacarpal prostheses, reusable surgical drill guides, and single-use screwdrivers, alongside sterilization containers and instrument trays for surgical use.

The company’s devices are classified under FDA regulations as Class I and Class II, with products listed in the FDA’s Unique Device Identification (UDI) database. The manufacturer operates from the United States, adhering to applicable U.S. medical device compliance requirements.

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

Frequently asked questions

What orthopaedic devices does Skeletal Dynamics LLC manufacture?

Skeletal Dynamics LLC manufactures orthopaedic fixation devices including non-sliding bone screws and non-bioabsorbable plating systems for elbow and humeral applications. Their portfolio also includes elbow and metacarpal prostheses, reusable surgical drill guides, single-use screwdrivers, sterilization containers, and instrument trays for surgical use.

Where is Skeletal Dynamics LLC based?

Skeletal Dynamics LLC is based in the United States, operating from within the country while adhering to applicable U.S. medical device compliance requirements for their orthopaedic devices.

Which regulatory registries list Skeletal Dynamics LLC's devices?

Skeletal Dynamics LLC's devices are listed in the FDA's Unique Device Identification (UDI) database, which tracks medical devices through their unique identifiers to ensure proper regulation and tracking.

How are Skeletal Dynamics LLC's devices classified?

Skeletal Dynamics LLC's devices are classified under FDA regulations as Class I and Class II medical devices, with Class I being lower risk and Class II requiring more regulatory controls but still considered moderate risk devices.

AI-generated from registry data and not verified by a human reviewer.

Information

Country: US
Address: —
Website: skeletaldynamics.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1(305)596-7585
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 869056148

Catalogue (1194)

Page 22 of 24

Device	Model / Reference	Registries	Class	Status
Distal Elbow Plating System	Screw, Polyaxial Locking, 3.0mm x 26mm Cannulated, CoCr	FDA UDI	Class II	Active
Distal Elbow Plating System	Screw, Multi-Thread Compression, 3.5mm x 24mm, Ti	FDA UDI	Class II	Active
Humeral Plating System	Depth Gauge, MT, 80mm	FDA UDI	Class II	Active
Humeral Plating System	Screw, Polyaxial Locking, 3.0mm x 54mm Cannulated, CoCr	FDA UDI	Class II	Active
Distal Elbow Plating System	Screw, Cortical Locking, 3.5mm x 20mm, Ti	FDA UDI	Class II	Active
Geminus	GEMINUS Drill Block, Sterilization Module	FDA UDI	Class II	Active
Distal Elbow Plating System	Threaded Peg, Cortical Non-Locking, 2.7 x 20 ,Ti	FDA UDI	Class II	Active
Ijs-E	IJS	FDA UDI	Class II	Active
Distal Elbow Plating System	Threaded Peg, Locking, 2.3mm x 36mm, Ti	FDA UDI	Class II	Active
Humeral Plating System	Distal Humerus Plate, Lateral Capitellur, 160mm, Left	FDA UDI	Class II	Active
Distal Elbow Plating System	Screw, Multi-Thread Locking, 3.5mm x 20mm, Ti	FDA UDI	Class II	Active
Align	ALIGN Radial Stem, 12mm x 6mm	FDA UDI	Class II	Active
Geminus	GEMINUS Drill Block, Right, Narrow	FDA UDI	Class II	Active
IMPlate	Unicortical Screw, 2.8mm x 7.0mm, Ti	FDA UDI	Class II	Active
REDUCT® Headless Compression Screw	Screw, Headless Compression, 2.5mm x 20mm, Ti	FDA UDI	Class II	Active
Ijs	IJS-E Axis Pin 2.5mm x 70mm	FDA UDI	Class II	Active
Dorsal Spanning Plate	Screw, Multi-Thread, Compression, 3.0mm x 10mm, Ti	FDA UDI	Class II	Active
Proximal Ulna Plate	Proximal Ulna Plating System, Sterilization Tray (Trifecta)	FDA UDI	Class II	Active
Distal Elbow Plating System	Proximal Ulna Plate, 108mm, Left	FDA UDI	Class II	Active
Humeral Fixation Set	FreeFix™, Distal Humerus Plate, Lateral Capitellar, 3 Hole, Left	FDA UDI	Class II	Active
Humeral Plating System	Screw, Multi-Thread, Compression, 2.7mm x 40mm, Ti	FDA UDI	Class II	Active
Geminus	Assembled, GEMINUS Volar Distal Radius Plate, Standrard, 125mm, Left	FDA UDI	Class II	Active
Geminus	Smooth Peg, Locking, 2.0mm x 18mm, Ti	FDA UDI	Class II	Active
Humeral Plating System	Distal Trochlea Compression Screw, 3.5mm x 70mm, Ti	FDA UDI	Class II	Active
Distal Elbow Plating System	Screw, Polyaxial Non Locking, 3.5mm x 12mm, Ti - OBSOLETE	FDA UDI	Class II	Active
Geminus	Screw, Polyaxial Locking, 2.5mm x 28mm Cannulated, CoCr	FDA UDI	Class II	Active
Align	Trial, Radial Stem, 6.0mm	FDA UDI	Class II	Active
Proximal Ulna Plate	FreeFix, Proximal Ulna Plate, 5 Slot Plus, Right	FDA UDI	Class II	Active
Stablyx	STABLYX, Metacarpal Rasp, Sz. 1	FDA UDI	Class II	Active
IMPlate	IMPLATE Connector, 7mm x 22.5°	FDA UDI	Class II	Active
Distal Elbow Plating System	Screw, Cortical Locking, 3.5mm x 40mm, Ti	FDA UDI	Class II	Active
Stablyx	STABLYX, CMC Trial, Sz. 1	FDA UDI	Class II	Active
Geminus	High Compression Locking Peg, 2.7mm x 18mm, Ti	FDA UDI	Class II	Active
Align	ALIGN, Trial, Radial Head, 22mm	FDA UDI	Class II	Active
IMPlate	IMPLATE Connector, 7mm x 7.5°	FDA UDI	Class II	Active
Threaded Hand Nail	Threaded Hand Nail, 2.0mm x 22mm, Ti	FDA UDI	Class II	Active
Geminus XL	GEMINUS XL System	FDA UDI	Class II	Active
Humeral Fixation Set	Distal Trochlea Compression Screw, 3.5mm x 60mm, Ti	FDA UDI	Class II	Active
Geminus	K-Wire, Standard Tip, 0.9mm x 152mm	FDA UDI	Class II	Active
Stablyx	STABLYX, Trapezial Sizer, Sz. 5	FDA UDI	Class II	Active
Threaded Hand Nail	Threaded Hand Nail, 3.0mm x 50mm, Ti	FDA UDI	Class II	Active
Distal Elbow Plating System	Screw, Multi-Thread Compression, 3.5mm x 18mm, Ti	FDA UDI	Class II	Active
Humeral Plating System	Distal Humerus Plate, Lateral Direct, 175mm, Left	FDA UDI	Class II	Active
Geminus	Pre-Loaded Drill Guide, 2.0mm (Magenta)	FDA UDI	Class II	Active
Humeral Plating System	Screw, Multi-Thread, Compression, 2.7mm x 50mm, Ti	FDA UDI	Class II	Active
IMPlate	Unicortical Screw, 2.8mm x 10.0mm, Ti	FDA UDI	Class II	Active
Distal Elbow Plating System	Screw, Multi-Thread Compression, 3.5mm x 38mm, Ti	FDA UDI	Class II	Active
Align	ALIGN, Head Alignment Tool, Radial Head Guide	FDA UDI	Class II	Active
REDUCT® Headless Compression Screw	Drill, Quick Connect, 2.7mm Cannulated	FDA UDI	Class II	Active
Geminus	High Compression Locking Peg, 2.7mm x 20mm, Ti	FDA UDI	Class II	Active

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