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510(k) Data Aggregation
K Number
K091493Device Name
ORTHO SELECT BONE PLATES AND SCREW SYSTEM
Manufacturer
ORTHO SELECT IMPLANT TECHNOLOGY GESELLSCHAFT
Date Cleared
2010-02-05
(261 days)
Product Code
HRS, HWC
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
ORTHO SELECT IMPLANT TECHNOLOGY GESELLSCHAFT
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ORTHO SELECT Bone Plates and Screw System is used for adult or pediatric patients as indicated for pelvic, small, and long bone fracture fixation. Indications for use include fractures of the tibia, fibula, femoral condyle, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, middle hand and middle foot bones; treatment of the calcaneal; and hip arthrodesis.
In pediatric patients, the ORTHO SELECT Bone Plates and Screw System is intended for use on mature bone only. It is not intended for placement across the growth plate.
Device Description
The ORTHO SELECT Bone Plates and Screw System consists of stainless steel bone plate and bone screw implants intended for internal fixation of pelvic, small and long bone fractures according to the standard of the AO Foundation (AO Principles of Fracture Management). The bone plates and screws are provided non-sterile for steam sterilization by user and single use only.
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