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510(k) Data Aggregation
K Number
K052483Device Name
SYNTHES (USA) SPHERICAL WASHERS
Manufacturer
SYNTHES (USA)
Date Cleared
2005-11-04
(56 days)
Product Code
NDG, HWC
Regulation Number
888.3030Why did this record match?
Product Code :
NDG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Synthes Spherical Washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/ load over a large area when used for fracture fixation of large (long) bone and bone fragments.
In addition, the Spherical Washers are intended to prevent the projection of the screw head, when the screw must be inserted at an acute angle (e.g., in ankle arthrodesis).
Device Description
The Spherical Washers are round or oval in design with a slotted center hole which allows for screw angulation up to 70 degrees. They are used with 4.5 - 7.3 mm diameter screws and manufactured from Stainless Steel and Titanium.
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