FDA.report

Product code KWP

Current FDA Classification

Device name
Appliance, Fixation, Spinal Interlaminal
Medical specialty
Orthopedic
Device class
2
Regulation number
888.3050
Review panel
OR
Implant
Y
Life sustaining/supporting
N
GMP exempt
N
Third party review
N
Summary malfunction reporting
Eligible

Related 510(k) Records

510(k)DeviceApplicantDecision date
K143278LnK Posterior Cervical Fixation SystemL&K BIOMED Co., Ltd.2015-07-29
K150753OASYS SystemStryker Corporation2015-06-09
K150851Sure Lok Mini Posterior Cervical/Upper Thoracic SystemPrecision Spine, Inc.2015-06-04
K142867Reliance Posterior Cervical-Thoracic SystemReliance Medical Systems, LLC2015-04-29
K150254Streamline OCT Occipito-Cervico-Thoracic SystemPioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.)2015-04-28
K142253SOLSTICE OCT SystemLife Spine, Inc.2015-04-23
K150229SOLSTICE OCT SystemLife Spine, Inc.2015-04-07
K143249SOLSTICE OCT SystemLife Spine, Inc.2015-04-07
K142741OASYS SystemStryker Corporation2015-01-15
K142558Caspian OCT/MESA Mini/DENALI Mini Spinal SystemK2m2014-12-22
K140734NEXTGEN ALTIUS OCT SYSTEMEbi, LLC2014-12-15
K142460EXPEDIUM Spine System/Synapse SystemJohnson and Johnson2014-10-01
K141897SYNAPSE SYSTEM, SYNTHES OC FUSION SYSTEMSynthes USA Products, LLC2014-09-25
K141284CASPIAN SPINAL SYSTEMK2m, Inc.2014-07-23
K133288CASPIAN OCT SPINAL SYSTEMK2m, Inc.2014-07-01
K133556VIRAGE OCT SPINAL FIXATION SYSTEMZimmer Spine, Inc.2014-06-02
K140645GIBRALT ROD-TO-ROD CROSS CONNECTORSExactech Sarasota2014-04-11
K133374STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEMPioneer Surgical Technology, Inc. (Rti Surgical, I2014-03-19
K133214BLACKBIRD SPINAL SYSTEMChoicespine, LP2014-03-07
K131833CENTURION POCT SYSTEMOrthofix, Inc.2014-01-30
K132122KESTREL POSTERIOR CERVICAL SPINE SYSTEMOmni Surgical, LLC Dba Spine3602014-01-22
K133698SYNAPSE SYSTEMSynthes USA Products, LLC2014-01-16
K133094CERTEX OCT SPINAL IMPLANT SYSTEMX-Spine Systems, Inc.2013-12-11
K132504TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEMCorelink, LLC2013-11-25
K132900MARAUDER CERVICAL-THORACIC SPINAL FIXATION SYSTEMIntelligent Implant Systems, LLC2013-10-25
K131427LOTUSSpinal Elements, Inc.2013-10-24
K132332MOUNTAINEER OCT SPINAL SYSTEMMedos International SARL2013-08-22
K131156LANX SPINAL FIXATION SYSTEMLanx, Inc.2013-05-24
K123906VERTEX RECONSTRUCTION SYSTEM, VERTEXT SELECT RECONSTRUCTION SYSTEMMedtronic Sofamor Danek USA, Inc.2013-04-01
K121979PASS OCT SPINAL SYSTEMMedicrea International2013-03-21

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