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510(k) Data Aggregation
K Number
K102834Device Name
ISO-ELASTIC CERCLAGE SYSTEM (1MM AND 2MM CABLE DIAMETER)
Manufacturer
KINAMED INCORPORATED
Date Cleared
2011-01-12
(105 days)
Product Code
JDQ
Regulation Number
888.3010Why did this record match?
Applicant Name (Manufacturer) :
KINAMED INCORPORATED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
- a. Repair of long bone fractures due to trauma or reconstruction;
- b. Reattachment of the greater trochanter in total hip arthroplasty, surface replacement arthroplasty, or other procedures involving trochanteric osteotomy;
- c. Sternotomy closure; and
- d. Sublaminar and Intrafacet wiring of the spinal column.
Device Description
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