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510(k) Data Aggregation
K Number
K150121Device Name
Zimmer Periarticular Plating System
Manufacturer
Date Cleared
2015-02-23
(34 days)
Product Code
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
ZIMMER,INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Periarticular Plating System plates are indicated for temporary internal fixation and stabilization of osteotomies and fractures, including: comminuted fractures, supracondylar fractures, intra-articular condylar fractures, fractures in osteopenic bone, nonunions, and malunions.
Periarticular Plating System Small Distal Volar Radial Radius and Small Distal Volar Ulnar Radius plates are indicated for temporary internal fixation and stabilization of fractures and osteotomies of the distal radius, including associated carpal fusions.
Periaticular Plating System Calcaneal plates are indicated for complex extra-articular fractures and osteotomies of the calcaneus.
Periatioular Plating System screws are temporary internal fixation devices designed to stabilize fractures during the normal healing process.
Device Description
The Zimmer Periarticular Plating System consists of temporary implants for the management of periarticular bone fractures through interfragmentary compression and bone plating. This submission covers various sizes of femoral, tibial, fibular, femoral, humeral, ulnar, and radial plates.
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