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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 5 of 24

Device	Model / Reference	Registries	Class	Status
Stablyx	STABLYX, Metacarpal Rasp, Sz. 3	FDA UDI	Class II	Active
IMPlate	IMPLATE Connector, 2mm x 7.5°	FDA UDI	Class II	Active
Humeral Plating System	Screw, Locking, FreeFix, 4.5mm x 26mm, Ti	FDA UDI	Class II	Active
Fragment Plate System	Assembled, Radial Column Plate, Left	FDA UDI	Class II	Active
Geminus	Threaded Peg, Locking, 2.3mm x 18mm, Ti	FDA UDI	Class II	Active
Geminus	Driver, Peg	FDA UDI	Class II	Active
Align	ALIGN, Trial, Radial Stem, 7.0mm	FDA UDI	Class II	Active
Humeral Plating System	Trochlear Compression Screw, Male, 55mm	FDA UDI	Class II	Active
Humeral Plating System	Screw, Locking, FreeFix, 4.5mm x 28mm, Ti	FDA UDI	Class II	Active
Distal Elbow Plating System	Screw, Cortical Locking, 3.5mm x 34mm, Ti	FDA UDI	Class II	Active
REDUCT® Headless Compression Screw	Screw, Headless Compression, 3.5mm x 30mm, Ti	FDA UDI	Class II	Active
Humeral Plating System	Distal Humerus Plate, Lateral Helical, 145mm, Right	FDA UDI	Class II	Active
Humeral Fixation Set	FreeFix™, Distal Humerus Plate, Medial Direct, 3 Hole, Left	FDA UDI	Class II	Active
Threaded Hand Nail	Threaded Hand Nail, 3.0mm x 35mm, Ti	FDA UDI	Class II	Active
Ijs	Screw, Polyaxial Non Locking, 3.5mm x 24mm, Ti	FDA UDI	Class II	Active
Ijs	IJS-E Axis Pin 2.5mm x 65mm	FDA UDI	Class II	Active
Geminus	Thread-in Drill Guide, 2.5mm	FDA UDI	Class II	Active
Geminus	Instrument, Key Periosteal Elevator, Standard	FDA UDI	Class II	Active
Align	ALIGN Radial Stem, 10mm x 2mm	FDA UDI	Class II	Active
Humeral Fixation Set	Large Reduction Forceps, Speed Lock	FDA UDI	Class II	Active
REDUCT® Headless Compression Screw	Screw, Headless Compression, 3.5mm x 19mm, Ti	FDA UDI	Class II	Active
Geminus	Smooth Peg, Locking, 2.0mm x 10mm, Ti	FDA UDI	Class II	Active
Proximal Ulna Plate	FreeFix, Proximal Ulna Plate, 3 Slot, Left	FDA UDI	Class II	Active
REDUCT® Headless Compression Screw	HCS Wire Pusher	FDA UDI	Class II	Active
Align	ALIGN, Radial Planer, Stem 9.0mm	FDA UDI	Class II	Active
IMPlate	IMPLATE Nail, Distal Radius, Long, Ti	FDA UDI	Class II	Active
Ijs-E	IJS	FDA UDI	Class II	Active
Stablyx	STABLYX, Metacarpal Planar, Sz. 1	FDA UDI	Class II	Active
Ijs	Screw, Polyaxial Non Locking, 3.5mm x 18mm, Ti	FDA UDI	Class II	Active
Distal Elbow Plating System	Screw, Multi-Thread Locking, 3.5mm x 65mm, Ti	FDA UDI	Class II	Active
Threaded Hand Nail	K-Wire, 0.9mm x 203mm, Single Trocar	FDA UDI	Class II	Active
Geminus	GEMINUS Volar Distal Radius Plate System - Instrument Tray	FDA UDI	Class II	Active
IMPlate	IMPLATE Uni Drill Guide, Depth Gauge	FDA UDI	Class II	Active
Align	Trial, Radial Head, 28mm	FDA UDI	Class II	Active
Distal Elbow Plating System	Screw, Multi-Thread Compression, 3.5mm x 8mm, Ti	FDA UDI	Class II	Active
Distal Elbow Plating System	Screw, Polyaxial Locking, 3.0mm x 34mm Cannulated, CoCr	FDA UDI	Class II	Active
Distal Elbow Plating System	Screw, Cortical Non Locking, 3.5mm x 30mm, Ti	FDA UDI	Class II	Active
Stablyx	Osteotome, Curved	FDA UDI	Class II	Active
Geminus	GEMINUS Select Implant Tray	FDA UDI	Class II	Active
Humeral Plating System	Driver, Universal, T15	FDA UDI	Class II	Active
Align	ALIGN, Sizer, Radial Head Implant	FDA UDI	Class II	Active
Distal Elbow Plating System	Screw, Multi-Thread Locking, 3.5mm x 40mm, Ti	FDA UDI	Class II	Active
Humeral Fixation Set	Threaded Peg, Fluted, Locking, 2.3mm x 40mm, Ti	FDA UDI	Class II	Active
Humeral Fixation Set	TiBeam™, Trochlea Compression Screw, Insertion Tool	FDA UDI	Class II	Active
Humeral Fixation Set	Drill, 3.2mm x 50mm, Reusable	FDA UDI	Class II	Active
Geminus XL	Geminus Plate, Narrow, 125mm, Left	FDA UDI	Class II	Active
Proximal Ulna Plate	FreeFix, Proximal Ulna Plate, 5 Slot Plus, Left	FDA UDI	Class II	Active
Humeral Fixation Set	Screw, Multi-Thread Locking, 3.5mm x 48mm, Ti	FDA UDI	Class II	Active
Ijs	IJS	FDA UDI	Class II	Active
Align	ALIGN Radial Stem, 7mm x 8mm	FDA UDI	Class II	Active

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