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510(k) Data Aggregation
K Number
K142111Device Name
ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLE
Manufacturer
NOVATSEP
Date Cleared
2014-12-19
(137 days)
Product Code
JDR
Regulation Number
888.3030Why did this record match?
Applicant Name (Manufacturer) :
NOVATSEP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The compressive osteosynthesis staples are indicated for hand and foot bone fragments osteotomy fixation and joint arthrodesis.
Device Description
Compressive osteosynthesis staples are single-use bone fixation appliances intended to be permanently implanted. ARCAD osteosynthesis staples are bipodal compression staples made of shape memory nickel titanium alloy.
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