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510(k) Data Aggregation
K Number
K031609Device Name
SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE SYSTEM
Manufacturer
Date Cleared
2003-06-09
(18 days)
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
SWISS ORTHOPEDIC SOLUTIONS INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Swiss Orthopedic Solutions Inc., Small Fragment Locking Plate Set is a plate and screw system, intended to treat fractures osteotomies and non-unions of various bones, including but not limited to, the radius, ulna, proximal and distal tibia, pelvis, clavicle, fibula, humerus and scapula particularly in osteopenic bone.
Device Description
The Swiss Orthopedic Solutions Inc. Small Fragment Locking Set is a plate and screw system. The available plate selection consists of straight, reconstruction, tubular, and various "T" and "L" shapes. The screws with the system are 3.6mm locking screws. The plates in the system can also accept standard spherical 2.7mm, 3.5mm and 4.0mm bone screws and cannulated bone screws. The plate features a hole that is fully threaded, allowing the use of any screw in a variety of positions. The system is available in either stainless steel or titanium.
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