Medical Device Manufacturer · US , Oceanside , CA

Solana Surgical, LLC - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2009
8
Total
8
Cleared
0
Denied
FDA 510(k) Regulatory Record - Solana Surgical, LLC Orthopedic ✕
8 devices
1-8 of 8
Cleared Dec 13, 2013
CROSSCHECK PLATING SYSTEM
K132594 · HRS
Orthopedic · 116d
Cleared Oct 22, 2013
LESSER METATARSAL HEAD IMPLANT SYSTEM
K131187 · KWD
Orthopedic · 179d
Cleared Jul 10, 2013
FUSEFORCE IMPLANT SYSTEM
K124045 · JDR
Orthopedic · 191d
Cleared Nov 07, 2012
GAITWAY IMPLANT SYSTEM, SURGICAL INSTRUMENT SET
K122738 · HWC
Orthopedic · 62d
Cleared Apr 10, 2012
SOLAFIX TWIST SCREW IMPLANT SYSTEM, SURGICAL INSTRUMENT SET
K120390 · HWC
Orthopedic · 63d
Cleared Feb 06, 2012
METATARSAL DECOMPRESSION IMPLANT SURGICAL INSTRUMENT SET
K113752 · KWD
Orthopedic · 47d
Cleared Feb 06, 2012
HEMI PHALANGEAL IMPLANT SURGICAL INSTRUMENT SET
K120029 · KWD
Orthopedic · 33d
Cleared May 01, 2009
METATARSAL DECOMPRESSION IMPLANT, MODEL 100
K090127 · KWD
Orthopedic · 100d
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