Ortho Solutions VOLITION™ Plating System. Catalog #OS731031L-NS

Vendor/Manufacturer: Ortho Solutions Group

Product/Product Line: Ortho Solutions VOLITION™ Plating System

Vendor/Manufacturer Catalog #: OS731031L-NS

Global Unique Device (GUD) Primary Device Identifier Number: 05055662963458

Global Unique Device (GUD) Device Description:

TIBIA PLATE, POSTERIOR 2B, LEFT

Global Medical Device Nomenclature (GMDN) Preferred Term Name:

Orthopaedic fixation plate, non-bioabsorbable, non-sterile

Global Medical Device Nomenclature (GMDN) Definition:

A non-sterile implantable sheet of firm material intended to be attached to fractured long bone fragments with screws to bridge and stabilize the fracture gap, and shield the site from stress as the bone heals; the material is not chemically degraded or absorbed by natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). The device is typically used to treat traumatic or pathological orthopaedic fractures; it may also be used to temporarily augment bone following a lengthening procedure, or for arthrodesis (joint fusion). This device is intended to 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): HRS

FDA Classification Product Code Device Name(s):

Plate, 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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