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510(k) Data Aggregation
K Number
K142135Device Name
REDUCE FRACTURE PLATING SYSTEM LINE EXTENSION
Manufacturer
ICON ORTHOPEDIC CONCEPTS, LLC DBA EDGE ORTHOPAEDIC
Date Cleared
2014-08-28
(24 days)
Product Code
HRS
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
ICON ORTHOPEDIC CONCEPTS, LLC DBA EDGE ORTHOPAEDIC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EDGE Orthopaedics' REDUCE® Fracture Plating System is intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The plates are available for use with EDGE Orthopaedics locking and non-locking bone screws.
Plates and screws are intended for single use only. Screws are not intended for use in the spine.
Device Description
The EDGE Orthopaedics' REDUCE® Fracture Plating System Line Extension has been designed to support multiple indications within the forefoot and mid-foot. The line extension includes titanium alloy, sterile packaged H and Box Plates along with sterile titanium alloy bone screws.
The REDUCE Fracture Plating System is offered in a variety of sizes for use with the nonlocking and locking bone screws. The screws are available in variety of diameters and lengths to help support the fixation, correction or stabilization of bones.
The corresponding instrumentation (depth gauges, screwdrivers, reamers, and plate benders) to facilitate insertion is found in EDGE's RIVAL Instrument Tray.
The only modifications that were made are the two additional fracture plates: H-plate and Box plate. The manufacturing, packaging and sterilization process are the same as the predicate device.
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K Number
K140876Device Name
VIEW PLATING SYSTEM,REDUCE FRACTURE PLATING SYSTEM,BONE SCREW
Manufacturer
ICON ORTHOPEDIC CONCEPTS, LLC DBA EDGE ORTHOPAEDIC
Date Cleared
2014-07-22
(106 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
ICON ORTHOPEDIC CONCEPTS, LLC DBA EDGE ORTHOPAEDIC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
EDGE Orthopaedics' VIEW™ and REDUCE™ Plating Systems are intended for use in stabilization and fixation of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The plates are available for use with EDGE Orthopaedics locking and non-locking bone screws.
Plates and screws are intended for single use only. Screws are not intended for use in the spine.
Device Description
The EDGE Orthopaedics' VIEW™ Plating System has been designed to support multiple indications within the mid-foot. The system includes titanium alloy, sterile packaged Lapidus, First Metatarsophalangeal (MTP), Calcaneal-Cuboid (CC), Evans and Talonavicular (TN) Plates along with sterile titanium alloy bone screws. The design creates a "window" offering a continuous view into the healing process.
The EDGE Orthopaedics' REDUCE® Fracture Plating System has been designed to support multiple indications within the forefoot and mid-foot. The system includes titanium alloy, sterile packaged T. L. Y. and Straight Plates along with sterile titanium alloy bone screws.
VIEW and REDUCE Plating Systems are offered in a variety of sizes for use with the nonlocking and locking bone screws. The screws are available in variety of diameters and lengths to help support the fixation, correction or stabilization of bones.
The corresponding instrumentation (depth gauges, screwdrivers, reamers, and plate benders) to facilitate insertion is found in EDGE's RIVAL Instrument Tray.
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