FDA 510(K), K150408 V-STEADY, V-FAST
FDA 510(K), K150408 V-STEADY, V-FAST
Device Classification Name Bone Cement
510(k) Number K150408
Device Name V-STEADY, V-FAST
Applicant G21 S.R.L.
Regulation Number 888.3027
Classification Product Code LOD
Subsequent Product Code NDN
Date Received 02/18/2015
Decision Date 12/14/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
Total pages: 99
Fully redacted pages: 65
Content pages: 34
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