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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 8 of 24

Device	Model / Reference	Registries	Class	Status
Geminus	Threaded Peg, Locking, 2.3mm x 12mm, Ti	FDA UDI	Class II	Active
Geminus	GEMINUS Volar Distal Radius Plate System Accessory Module 1, 304	FDA UDI	Class II	Active
Geminus	Threaded Peg, Locking, 2.3mm x 30mm, Ti	FDA UDI	Class II	Active
Geminus	Depth Gauge, Universal, 30mm	FDA UDI	Class II	Active
Threaded Hand Nail	Guide Wire Introducer	FDA UDI	Class II	Active
Humeral Fixation Set	Screw, FreeFix™ Compression, 3.5mm x 18mm, Ti	FDA UDI	Class II	Active
IMPlate	IMPLATE Rasp 1, Distal Radius, 5.5mm x 70mm	FDA UDI	Class II	Active
Geminus	Drill, Cannulated, Polyaxial Locking Screw, 2.0mm	FDA UDI	Class II	Active
Distal Elbow Plating System	Threaded Peg, Locking, 2.3mm x 6mm, Ti	FDA UDI	Class II	Active
Align	ALIGN Radial Stem, 8mm x 8mm	FDA UDI	Class II	Active
Ijs	IJS-E Drill, Cann Distal Cutting, 2.7mm x 70mm	FDA UDI	Class II	Active
Align	ALIGN Radial Head System	FDA UDI	Class II	Active
Stablyx	STABLYX, Trapezial Sizer, Sz. 3	FDA UDI	Class II	Active
Distal Elbow Plating System	Threaded Peg, Non-Locking, 2.7mm x 6mm, Ti	FDA UDI	Class II	Active
Ulna Shortening Plating System	Ulnar Shortening, Cutting Guide, Oblique, Proximal, Left	FDA UDI	Class II	Active
Humeral Plating System	Screw, Locking, FreeFix, 4.5mm x 34mm, Ti	FDA UDI	Class II	Active
Threaded Hand Nail	Threaded Hand Nail, 3.0mm x 25mm, Ti	FDA UDI	Class II	Active
Distal Elbow Plating System	Distal Elbow System, Tray A - OBSOLETE	FDA UDI	Class II	Active
Threaded Hand Nail	Threaded Hand Nail, 4.5mm x 60mm, Ti	FDA UDI	Class II	Active
Humeral Fixation Set	Humeral Fixation Set Tray A	FDA UDI	Class II	Active
Distal Elbow Plating System	Screw, Multi-Thread Locking, 3.5mm x 8mm, Ti	FDA UDI	Class II	Active
Fragment Plate System	Assembled, Radial Column Plate, Right	FDA UDI	Class II	Active
Geminus	Screw, Polyaxial Locking, 2.5mm x 20mm Cannulated, CoCr	FDA UDI	Class II	Active
REDUCT® Headless Compression Screw	Screw, Headless Compression, 2.5mm x 26mm, Ti	FDA UDI	Class II	Active
IMPlate	IMPLATE Reamer 1, Metacarpal, 2.7mm x 87mm	FDA UDI	Class II	Active
Geminus	GEMINUS Hook Plate Snap-in Block	FDA UDI	Class II	Active
Align	ALIGN Radial Stem, 7mm x 2mm	FDA UDI	Class II	Active
Threaded Hand Nail	Threaded Hand Nail, 2.0mm x 24mm, Ti	FDA UDI	Class II	Active
Distal Elbow Plating System	Screw, Multi-Thread Locking, 3.5mm x 14mm, Ti	FDA UDI	Class II	Active
Forearm Plating System	FreeFix Midshaft Radius Plate, 97mm	FDA UDI	Class II	Active
Distal Elbow Plating System	Screw, Multi-Thread Locking, 3.5mm x 45mm, Ti	FDA UDI	Class II	Active
Humeral Fixation Set	Screw, Multi-Thread, Compression, 2.7mm x 42mm, Ti	FDA UDI	Class II	Active
Geminus XL	Geminus Plate, Standard, 165mm, Left	FDA UDI	Class II	Active
Geminus	GEMINUS VDR Plate, Standard, 3 Hole, Left	FDA UDI	Class II	Active
Geminus	Screw, Cortical Non Locking, 3.5mm x 14mm, Ti	FDA UDI	Class II	Active
Humeral Fixation Set	Drill, 2.7mm x 50mm, Reusable	FDA UDI	Class II	Active
Humeral Fixation Set	Distal Trochlea Compression Screw, 3.5mm x 35mm, Ti	FDA UDI	Class II	Active
Humeral Plating System	K-Wire, Single Trocar, 1.5 mm x 229 mm	FDA UDI	Class II	Active
Stablyx	STABLYX, CMC Implant, Sz. 3	FDA UDI	Class II	Active
Forearm Plating System	FreeFix Midshaft Ulna Plate, 112mm	FDA UDI	Class II	Active
IMPlate	IMPlate Sterilization Tray, Base	FDA UDI	Class II	Active
Humeral Fixation Set	Cannulated Depth Gauge, Polyaxial Locking Screw, 3.0mm x 70mm	FDA UDI	Class II	Active
Align	ALIGN Radial Stem, 6mm x 6mm	FDA UDI	Class II	Active
Distal Elbow Plating System	Screw, Multi-Thread Compression, 3.5mm x 65mm, Ti	FDA UDI	Class II	Active
Align	ALIGN, Trial, Radial Neck, 4.0mm	FDA UDI	Class II	Active
Humeral Plating System	Distal Humerus Plate, Medial Direct, 105mm, Left	FDA UDI	Class II	Active
IMPlate	IMPLATE Reamer 2, Metacarpal, 3.4mm x 87mm	FDA UDI	Class II	Active
Stablyx	STABLYX, CMC Implant, Sz. 1	FDA UDI	Class II	Active
Geminus	Threaded Peg, Non-Locking, 2.7mm x 30mm, Ti	FDA UDI	Class II	Active
Threaded Hand Nail	Threaded Hand Nail, 2.0mm x 12mm, Ti	FDA UDI	Class II	Active

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