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Solana Surgical, LLC

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
8
Inspections
1
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K132594CROSSCHECK PLATING SYSTEMDecember 13, 2013
K131187LESSER METATARSAL HEAD IMPLANT SYSTEMOctober 22, 2013
K124045FUSEFORCE IMPLANT SYSTEMJuly 10, 2013
K122738GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SETNovember 7, 2012
K120390SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SETApril 10, 2012
K113752METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SETFebruary 6, 2012
K120029HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SETFebruary 6, 2012
K090127METATARSAL DECOMPRESSION IMPLANT, MODEL 100May 1, 2009