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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 11 of 24

Device	Model / Reference	Registries	Class	Status
Align	ALIGN, Radial Planer, Stem 10.0mm	FDA UDI	Class II	Active
Ulna Shortening Plating System	Drill Guide, FreeFixTM, Ulnar Shortening	FDA UDI	Class II	Active
Dorsal Spanning Plate	Screw, Multi-Thread, Locking, 3.0mm x 14mm, Ti	FDA UDI	Class II	Active
Humeral Fixation Set	FreeFix™, Distal Humerus Plate, Lateral Helical, 9 Hole, Left	FDA UDI	Class II	Active
Stablyx	STABLYX, CMC Implant, Sz. 1	FDA UDI	Class II	Active
IMPlate	IMPlate Sterilization Tray, Lid	FDA UDI	Class II	Active
Humeral Fixation Set	FreeFix™, Distal Humerus Plate, Medial Direct, 3 Hole, Right	FDA UDI	Class II	Active
Stablyx	STABLYX, Trapezial Sizer, Sz. 3	FDA UDI	Class II	Active
Threaded Hand Nail	Threaded Hand Nail, 2.0mm x 28mm, Ti	FDA UDI	Class II	Active
Geminus XL	Geminus Plate, Standard, 200mm, Left	FDA UDI	Class II	Active
Humeral Fixation Set	Screw, Polyaxial Locking, 3.0mm x 14mm Cannulated, CoCr	FDA UDI	Class II	Active
Humeral Plating System	Distal Trochlea Compression Screw, 3.5mm x 65mm, Ti	FDA UDI	Class II	Active
Humeral Fixation Set	Drill, 2.7mm x 50mm	FDA UDI	Class II	Active
Humeral Fixation Set	TiBeam™, Trochlea Compression Screw, Male, 60mm	FDA UDI	Class II	Active
Humeral Plating System	Screw, Locking, FreeFix, 4.5mm x 16mm, Ti	FDA UDI	Class II	Active
Distal Elbow Plating System	Threaded Peg, Cortical Non-Locking, 2.7 x 18 ,Ti	FDA UDI	Class II	Active
Align	ALIGN, Radial Rasp, Stem 10.0mm	FDA UDI	Class II	Active
Proximal Ulna Plate	PUP Extension, 2 Hole	FDA UDI	Class II	Active
Ijs	IJS	FDA UDI	Class II	Active
Ijs	Screw, Polyaxial Non Locking, 3.5mm x 20mm, Ti	FDA UDI	Class II	Active
IMPlate	Unicortical Screw, 2.8mm x 6.0mm, Ti	FDA UDI	Class II	Active
Geminus	Threaded Peg, Locking, 2.3mm x 26mm, Ti	FDA UDI	Class II	Active
Align	ALIGN Radial Stem, 9mm x 8mm	FDA UDI	Class II	Active
Humeral Fixation Set	Screw, FreeFix™ Locking, 4.5mm x 34mm, Ti	FDA UDI	Class II	Active
Humeral Fixation Set	Off Axis Drill Guide, FreeFix™ 4.5mm	FDA UDI	Class II	Active
Forearm Plating System	FreeFix Midshaft Radius Plate, 112mm	FDA UDI	Class II	Active
Distal Elbow Plating System	Screw, Multi-Thread Compression, 3.5mm x 28mm, Ti	FDA UDI	Class II	Active
REDUCT® Headless Compression Screw	Screw, Headless Compression, 3.5mm x 12mm, Ti	FDA UDI	Class II	Active
Geminus XL	Geminus Plate, Narrow, 200mm, Right	FDA UDI	Class II	Active
Distal Elbow Plating System	Screw, Multi-Thread Compression, 3.5mm x 50mm, Ti	FDA UDI	Class II	Active
Geminus XL	Geminus Plate, Narrow, 165mm, Left	FDA UDI	Class II	Active
Distal Elbow Plating System	Screw, Cortical Non Locking, 3.5mm x 34mm, Ti	FDA UDI	Class II	Active
Geminus	High Compression Locking Peg, 2.7mm x 30mm, Ti	FDA UDI	Class II	Active
Align	ALIGN, Radial Planer, Stem 8.0mm	FDA UDI	Class II	Active
Distal Elbow Plating System	Screw, Cortical Non Locking, 3.5mm x 17mm, Ti	FDA UDI	Class II	Active
Humeral Plating System	Screw, Locking, FreeFix, 4.5mm x 32mm, Ti	FDA UDI	Class II	Active
Humeral Fixation Set	Humeral Fixation Set Tray B, Top Insert	FDA UDI	Class II	Active
Humeral Plating System	Midshaft Humerus Plate, Narrow 208mm	FDA UDI	Class II	Active
IMPlate	IMPLATE Lock Screw, Unicort. Drill Guide	FDA UDI	Class II	Active
IMPlate	Unicortical Screw, 2.8mm x 8.0mm, Ti	FDA UDI	Class II	Active
Geminus	High Compression Locking Peg, 2.7mm x 16mm, Ti	FDA UDI	Class II	Active
Ulna Shortening Plating System	Instrument, Hohmann Retractor, Double Ended	FDA UDI	Class II	Active
Humeral Fixation Set	FreeFix™, Distal Humerus Plate, Lateral Helical, 3 Hole, Right	FDA UDI	Class II	Active
Geminus	Screw, Cortical Locking, 3.5mm x 16mm, Ti	FDA UDI	Class II	Active
Geminus	K-Wire, 1.6mm x 127mm	FDA UDI	Class II	Active
Geminus	Pre-Loaded Drill Guide, 2.0mm (Green)	FDA UDI	Class II	Active
Align	ALIGN Radial Stem, 6mm x 0mm	FDA UDI	Class II	Active
Distal Elbow Plating System	Distal Elbow Set Tray A	FDA UDI	Class II	Active
Dorsal Spanning Plate	Screw, Multi-Thread, Compression, 3.0mm x 16mm, Ti	FDA UDI	Class II	Active
Humeral Plating System	Screw, Compression, 4.5mm x 20mm, Ti	FDA UDI	Class II	Active

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