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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 18 of 24

Device	Model / Reference	Registries	Class	Status
Distal Elbow Plating System	Proximal Ulna Plate, 108mm, Right	FDA UDI	Class II	Active
Humeral Fixation Set	Humeral Fixation Set Tray B, Lid	FDA UDI	Class II	Active
Stablyx	STABLYX System Lid	FDA UDI	Class II	Active
Geminus	Screw, Cortical Non Locking, 3.5mm x 10mm, Ti	FDA UDI	Class II	Active
Humeral Fixation Set	FreeFix™, Distal Humerus Plate, Medial Direct, 6 Hole, Right	FDA UDI	Class II	Active
Align	ALIGN Radial Head & Lock Screw, 24mm	FDA UDI	Class II	Active
Humeral Fixation Set	Countersink, 6.5mm, Reusable	FDA UDI	Class II	Active
Stablyx	STABLYX, Metacarpal Rasp, Sz. 2	FDA UDI	Class II	Active
Humeral Fixation Set	Drill, Cannulated, 4.0mm x 20mm	FDA UDI	Class II	Active
Geminus	GEMINUS Volar Distal Radius Plate, Standard, 4 Hole, Left	FDA UDI	Class II	Active
Align	ALIGN Radial Stem, Long Trial 6.0mm	FDA UDI	Class II	Active
Geminus	Screw, Cortical Non Locking, 3.5mm x 11mm, Ti	FDA UDI	Class II	Active
Humeral Plating System	Trochlear Compression Screw, Male, 45mm	FDA UDI	Class II	Active
Geminus	Threaded Peg, Locking, 2.3mm x 24mm, Ti	FDA UDI	Class II	Active
Stablyx	STABLYX, Metacarpal Rasp, Sz. 2	FDA UDI	Class II	Active
Geminus	Drill, Solid Side Cutting, 2.0mm x 40mm	FDA UDI	Class II	Active
Stablyx	STABLYX CMC Arthroplasty System Sterilization Tray	FDA UDI	Class II	Active
Dorsal Spanning Plate	Screw, Multi-Thread, Compression, 3.0mm x 14mm, Ti	FDA UDI	Class II	Active
Geminus	Handle, Universal Quick Connect, Fixed	FDA UDI	Class II	Active
Humeral Fixation Set	FreeFix™, Distal Humerus Plate, Lateral Direct, 3 Hole, Left	FDA UDI	Class II	Active
Align	ALIGN, Sterilization Tray, Base	FDA UDI	Class II	Active
Stablyx	STABLYX, Trapezial Sizer, Sz. 2	FDA UDI	Class II	Active
Humeral Plating System	Trochlear Compression Screw, Male, 70mm	FDA UDI	Class II	Active
Geminus	GEMINUS Drill Block System	FDA UDI	Class II	Active
Distal Elbow Plating System	Proximal Ulna Plate, 73mm, Left	FDA UDI	Class II	Active
Stablyx	STABLYX, Volar Osteophyte Rasp	FDA UDI	Class II	Active
Humeral Plating System	Drill Guide, FreeFix™, HPS	FDA UDI	Class II	Active
Stablyx	STABLYX, Metacarpal Rasp, Sz. 5	FDA UDI	Class II	Active
Implate	IMPLATE Connector, 12mm x 10°	FDA UDI	Class I	Active
Geminus	Pre-Loaded Drill Guide, 2.0mm (Blue)	FDA UDI	Class II	Active
REDUCT® Headless Compression Screw	Screw, Headless Compression, 3.5mm x 16mm, Ti	FDA UDI	Class II	Active
Threaded Hand Nail	Threaded Hand Nail, 3.5mm x 50mm, Ti	FDA UDI	Class II	Active
Humeral Fixation Set	FreeFix™, Distal Humerus Plate, Medial Direct, 5 Hole, Right	FDA UDI	Class II	Active
Proximal Ulna Plate	FreeFix, Proximal Ulna Plate, 5 Slot, Left	FDA UDI	Class II	Active
Align	ALIGN Radial Stem, 6mm x 8mm	FDA UDI	Class II	Active
Geminus	GEMINUS VDR Plate, Narrow, 4 Hole, Left	FDA UDI	Class II	Active
Humeral Fixation Set	Threaded Peg, Fluted, Locking, 2.3mm x 10mm, Ti	FDA UDI	Class II	Active
Humeral Fixation Set	Screw, FreeFix™ Locking, 3.5mm x 32mm, Ti	FDA UDI	Class II	Active
Geminus	GEMINUS Volar Distal Radius Plate, Standard, 3 Hole, Right	FDA UDI	Class II	Active
Distal Elbow Plating System	Cannulated Depth Gauge, Polyaxial Locking Screw, 3.0mm	FDA UDI	Class II	Active
Threaded Hand Nail	K-Wire Exchanger	FDA UDI	Class II	Active
Geminus	GEMINUS Volar Distal Radius Plate System Base	FDA UDI	Class II	Active
Humeral Fixation Set	Humeral Fixation Set Tray B, Middle Insert	FDA UDI	Class II	Active
Distal Elbow Plating System	Screw, Polyaxial Locking, 3.0mm x 36mm Cannulated, CoCr	FDA UDI	Class II	Active
Distal Elbow Plating System	Screw, Cortical Locking, 3.5mm x 32mm, Ti	FDA UDI	Class II	Active
Stablyx	STABLYX, Trapezial Contouring Tool, Sz. 1	FDA UDI	Class II	Active
Threaded Hand Nail	Threaded Hand Nail, 2.0mm x 26mm, Ti	FDA UDI	Class II	Active
Humeral Fixation Set	Screw, Polyaxial Locking, 3.0mm x 16mm Cannulated, CoCr	FDA UDI	Class II	Active
Geminus	Screw, Cortical Locking, 3.5mm x 10mm, Ti	FDA UDI	Class II	Active
Humeral Fixation Set	Screw, FreeFix™ Locking, 3.5mm x 26mm, Ti	FDA UDI	Class II	Active

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