FDA.reportPublic FDA data

Device Listing 1765081082

Listing Summary#

Listing key
1765081082
Premarket submission
K092381
Device
IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT AND ANCHOR, AKRFX INSTRUMENTATION
Applicant
Ibalance Medical, Inc.
Product code
HRS
Decision date
2009-10-27