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510(k) Data Aggregation
K Number
K142484Device Name
Sternal Closure System
Manufacturer
Date Cleared
2014-10-31
(57 days)
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
JACE Medical LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Sternal Closure System is intended for use in the stabilization of fractures of the sternum, including sternal fixation following sternotomy and sternal reconstructive surgical procedures.
Device Description
The Sternal Closure System is comprised of bone screw, bone plate and fastener components and instruments for implantation. The plates are offered in a fixed one-piece and a fastenable two-piece style. Bone screws are available in a single diameter having a range of lengths. The interconnecting components come in solid and cable versions and fasten the halves of the two-piece plate.
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