Ortho Solutions VOLITION™ Plating System. Catalog #OS704054-NS

Vendor/Manufacturer: Ortho Solutions Group

Product/Product Line: Ortho Solutions VOLITION™ Plating System

Vendor/Manufacturer Catalog #: OS704054-NS

Global Unique Device (GUD) Primary Device Identifier Number: 05055662968040

Global Unique Device (GUD) Device Description:

LOCKING SCREW, 4.0 X 54MM

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Orthopaedic bone screw, non-bioabsorbable, non-sterile

Global Medical Device Nomenclature (GMDN) Definition:

A small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

FDA Regulation Medical Specialty:

Orthopedic Devices - Prosthetic Devices

FDA Regulation Number: 888.3030

FDA Regulation Description Classification Name:

Single/multiple component metallic bone fixation appliances and accessories

FDA Classification Product Code(s): HWC

FDA Classification Product Code Device Name(s):

Screw, Fixation, Bone

FDA Premarket Submission: K202764 The Ortho Solutions VOLITION™ Plating System is SUBSTANTIALLY EQUIVALENT to the following product(s): 1. Wright Medical ORTHOLOC 3Di Ankle Fracture Plating System

2. Ortho Solutions Trauma Plates for Osteosynthesis

3. Ortho Solutions UltOS Plating System

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