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MNI — Orthosis, Spinal Pedicle Fixation Class II

FDA Device Classification

Classification Details

Product Code
MNI
Device Class
Class II
Regulation Number
888.3070
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K171497mikron makina sanayi ticaret co.Mikron Spinal Fixation SystemOctober 12, 2017
K160731cg bio coLumFix Spinal Fixation SytemOctober 4, 2016
K151458double medical technologyDouble Medical Universal Spine SystemAugust 22, 2016
K153273medacta internationalMySpine Pedicle Screw Placement Guides - LPJune 29, 2016
K160124spinevisionLUMIS Cannulated Pedicle Screw Fixation System, U.L.I.S. Pedicle Screw Fixation April 4, 2016
K160320shandong weigao orthopaedic device coPremierApril 1, 2016
K160003spine waveSniper (R) Spine SystemFebruary 26, 2016
K152324beijing weigao yahua artificial joint development co.YAHUA Spinal SystemFebruary 1, 2016
K143222mighty oak medicalFIREFLY Pedicle Screw Navigation GuideDecember 11, 2015
K150684changzhou waston medical appliance coWASTON General Spinal SystemNovember 18, 2015
K152132x-spine systemsX-spine Pedicle Screw SystemSeptember 25, 2015
K151592suzhou gemmed medical instrument coGemmed pedicle screw spinal systemSeptember 24, 2015
K152098kisco internationalODALYS Pedicle Screw SystemSeptember 17, 2015
K152131reliance medical systemsReliance Spinal Screw SystemSeptember 17, 2015
K152174spine waveSniper Spine SystemAugust 31, 2015
K151813spine waveSniper Spine SystemJuly 31, 2015
K150294osteomed implantes, ltdaDPZ Pedicular Fixation SystemJune 5, 2015
K150647new era orthopedicsPolyscrew Pedicle Screw SystemApril 8, 2015
K150049medicrea internationalPASS LP Spinal SystemFebruary 10, 2015
K141253new era orthopaedicsNEW ERA ORTHOPAEDICS POLYSCREW PEDICLE SCREW SYSTEMJanuary 9, 2015