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510(k) Data Aggregation
K Number
K023594Device Name
TENO FIX
Manufacturer
ORTHEON MEDICAL, LLC.
Date Cleared
2003-05-15
(202 days)
Product Code
GAQ
Regulation Number
878.4495Why did this record match?
Applicant Name (Manufacturer) :
ORTHEON MEDICAL, LLC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ortheon Medical Teno Fix™ tendon repair system is indicated for the repair of severed or lacerated digital flexor tendons.
Device Description
The Teno Fix™ Tendon Repair System is delivered sterile. It consists of the implantable stainless steel components, implantation accessories, and installation instruments. The implantable components of the device include the anchors, stop beads, and suture. The stainless steel suture is shipped pre-assembled with a crimped stop bead and tapered needle.
The Teno Fix™ Tendon Repair System is supplied with two preloaded, single-use disposable installation instruments for implantation of the Teno Fix™ anchors. A crimping instrument is supplied to crimp the stop bead to the stainless steel core suture thus controlling the overall length of the implanted device.
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