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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 6 of 24

Device	Model / Reference	Registries	Class	Status
Humeral Fixation Set	Distal Humerus Plate, Supracondylar, 8 Hole, Left	FDA UDI	Class II	Active
Geminus	Smooth Peg, Locking, 2.0mm x 17mm, Ti	FDA UDI	Class II	Active
Align	ALIGN, Radial Rasp, Stem 11.0mm	FDA UDI	Class II	Active
Threaded Hand Nail	Countersink, 3.3mm, Cannulated	FDA UDI	Class II	Active
Humeral Plating System	Screw, Multi-Thread, Locking, 2.7mm x 14mm, Ti	FDA UDI	Class II	Active
Humeral Fixation Set	HPS PLS K-Wire Guide	FDA UDI	Class II	Active
Humeral Fixation Set	Screw, FreeFix™ Compression, 4.5mm x 36mm, Ti	FDA UDI	Class II	Active
Align	Radial Rasp, Stem 12.0mm	FDA UDI	Class II	Active
Humeral Fixation Set	Screw, Multi-Thread, Compression, 2.7mm x 48mm, Ti	FDA UDI	Class II	Active
Humeral Plating System	Distal Humerus Plate, Lateral Direct, 175mm, Right	FDA UDI	Class II	Active
IMPlate	IMPLATE Uni Drill Guide, DRMC Nails	FDA UDI	Class II	Active
Humeral Fixation Set	Screw, Multi-Thread, Locking, 2.7mm x 34mm, Ti	FDA UDI	Class II	Active
Humeral Fixation Set	Tissue Protector / Drill Guide, Dual Sided, 2.7mm x 3.5mm	FDA UDI	Class II	Active
Stablyx	STABLYX, CMC Trial, Sz. 4	FDA UDI	Class II	Active
Distal Elbow Plating System	Threaded Peg, Non-Locking, 2.7mm x 9mm, Ti	FDA UDI	Class II	Active
Align	ALIGN Radial Stem, Long Trial 9.0mm	FDA UDI	Class II	Active
Stablyx	STABLYX, Trapezial Contouring Tool, Sz. 1	FDA UDI	Class II	Active
Humeral Fixation Set	Drill, 2.7mm x 80mm, Reusable	FDA UDI	Class II	Active
Distal Elbow Plating System	Screw, Multi-Thread Compression, 3.5mm x 34mm, Ti	FDA UDI	Class II	Active
Ijs	IJS	FDA UDI	Class II	Active
Threaded Hand Nail	Threaded Hand Nail, 4.5mm x 35mm, Ti	FDA UDI	Class II	Active
Stablyx	STABLYX, CMC Implant, Sz. 4	FDA UDI	Class II	Active
Humeral Fixation Set	Screw, FreeFix™ Compression, 3.5mm x 32mm, Ti	FDA UDI	Class II	Active
Humeral Fixation Set	Screw, Multi-Thread, Locking, 2.7mm x 44mm, Ti	FDA UDI	Class II	Active
Humeral Fixation Set	Screw, FreeFix™ Compression, 3.5mm x 26mm, Ti	FDA UDI	Class II	Active
REDUCT® Headless Compression Screw	Screw, Headless Compression, 2.5mm x 12mm, Ti	FDA UDI	Class II	Active
Stablyx	STABLYX System Lid	FDA UDI	Class II	Active
Align	ALIGN, Neck Gauge & Head Inserter, 6mm	FDA UDI	Class II	Active
Ijs	IJS	FDA UDI	Class II	Active
IMPlate	IMPLATE Wrist Arthrodesis Nail System	FDA UDI	Class II	Active
Stablyx	STABLYX, Metacarpal Rasp, Sz. 1	FDA UDI	Class II	Active
Stablyx	STABLYX, Trapezial Sizer, Sz. 5	FDA UDI	Class II	Active
Distal Elbow Plating System	Screw, Polyaxial Locking, 3.0mm x 24mm Cannulated, CoCr	FDA UDI	Class II	Active
Humeral Plating System	Screw, Locking, FreeFix, 4.5mm x 18mm, Ti	FDA UDI	Class II	Active
Humeral Plating System	Screw, Multi-Thread, Locking, 2.7mm x 10mm, Ti	FDA UDI	Class II	Active
Humeral Fixation Set	Screw, FreeFix™ Compression, 4.5mm x 16mm, Ti	FDA UDI	Class II	Active
Humeral Plating System	Distal Humerus Plate, Lateral Direct, 145mm, Left	FDA UDI	Class II	Active
Humeral Fixation Set	Humeral Fixation System A	FDA UDI	Class II	Active
Distal Elbow Plating System	Screw, Multi-Thread Compression, 3.5mm x 12mm, Ti	FDA UDI	Class II	Active
Geminus	Screw, Cortical Non Locking, 3.5mm x 9mm, Ti	FDA UDI	Class II	Active
Align	Radial Planer, Stem 12.0mm	FDA UDI	Class II	Active
Threaded Hand Nail	Driver, Universal QC, T8	FDA UDI	Class II	Active
Humeral Fixation Set	Screw, FreeFix™ Compression, 3.5mm x 14mm, Ti	FDA UDI	Class II	Active
Stablyx	STABLYX CMA Instrument Tray Insert	FDA UDI	Class II	Active
Align	ALIGN Radial Stem, 8mm x 6mm	FDA UDI	Class II	Active
Align	ALIGN, Stem Impactor	FDA UDI	Class II	Active
Humeral Fixation Set	Screw, FreeFix™ Locking, 4.5mm x 32mm, Ti	FDA UDI	Class II	Active
Distal Elbow Plating System	Screw, Multi-Thread Locking, 3.5mm x 55mm, Ti	FDA UDI	Class II	Active
Implate	IMPLATE Connector, 2mm x 10°	FDA UDI	Class I	Active
IMPlate	IMPLATE Reamer 3, Metacarpal, 4.0mm x 87mm	FDA UDI	Class II	Active

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