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IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT AND ANCHOR, AKRFX INSTRUMENTATION

Page Type
Cleared 510(K)
510(k) Number
K092381
510(k) Type
Traditional
Applicant
IBALANCE MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/27/2009
Days to Decision
83 days
Submission Type
Summary

IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT AND ANCHOR, AKRFX INSTRUMENTATION

Page Type
Cleared 510(K)
510(k) Number
K092381
510(k) Type
Traditional
Applicant
IBALANCE MEDICAL, INC.
Country
United States
FDA Decision
Substantially Equivalent
Decision Date
10/27/2009
Days to Decision
83 days
Submission Type
Summary