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KWP — Appliance, Fixation, Spinal Interlaminal Class II

FDA Device Classification

Classification Details

Product Code
KWP
Device Class
Class II
Regulation Number
888.3050
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K143278l and k biomed coLnK Posterior Cervical Fixation SystemJuly 29, 2015
K150753stryker corporationOASYS SystemJune 9, 2015
K150851precision spineSure Lok Mini Posterior Cervical/Upper Thoracic SystemJune 4, 2015
K142867reliance medical systemsReliance Posterior Cervical-Thoracic SystemApril 29, 2015
K150254pioneer surgical technology, inc. (dba rti surgical, inc.)Streamline OCT Occipito-Cervico-Thoracic SystemApril 28, 2015
K142253life spineSOLSTICE OCT SystemApril 23, 2015
K150229life spineSOLSTICE OCT SystemApril 7, 2015
K143249life spineSOLSTICE OCT SystemApril 7, 2015
K142741stryker corporationOASYS SystemJanuary 15, 2015
K142558k2mCaspian OCT/MESA Mini/DENALI Mini Spinal SystemDecember 22, 2014
K140734ebiNEXTGEN ALTIUS OCT SYSTEMDecember 15, 2014
K142460johnson and johnsonEXPEDIUM Spine System/Synapse SystemOctober 1, 2014
K141897synthes usa productsSYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEMSeptember 25, 2014
K141284k2mCASPIAN SPINAL SYSTEMJuly 23, 2014
K133288k2mCASPIAN OCT SPINAL SYSTEMJuly 1, 2014
K133556zimmer spineVIRAGE OCT SPINAL FIXATION SYSTEMJune 2, 2014
K140645exactech sarasotaGIBRALT ROD-TO-ROD CROSS CONNECTORSApril 11, 2014
K133374pioneer surgical technology, inc. (rti surgical, iSTREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEMMarch 19, 2014
K133214choicespineBLACKBIRD SPINAL SYSTEMMarch 7, 2014
K131833orthofixCENTURION POCT SYSTEMJanuary 30, 2014