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510(k) Data Aggregation
K Number
K073226Device Name
CINCH KNOTLESS FIXATION IMPLANT SYSTEM
Manufacturer
C2M MEDICAL, INC.
Date Cleared
2007-12-07
(22 days)
Product Code
MBI
Regulation Number
888.3040Why did this record match?
Applicant Name (Manufacturer) :
C2M MEDICAL, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The CINCH™ Knotless Fixation Implant System is intended for the fixation of soft tissue to bone during rotator cuff repair.
Device Description
The CINCHT™ Knotless Fixation Implant includes single-use, sterile Anchor (3.5mm in diameter), which is preloaded onto a disposable anchor inserters. The CINCH™ Knotless Fixation Implant System is comprised of nondegradable suture anchors each pre-loaded onto an inserter.
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