{"database": "openregs", "table": "documents", "is_view": false, "human_description_en": "where agency_id = \"FDA\" and docket_id = \"FDA-2014-N-1205\" sorted by posted_date descending", "rows": [["FDA-2014-N-1205-0031", "FDA", "FDA-2014-N-1205", "Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems", "Rule", "Correction", "2017-01-09T05:00:00Z", 2017, 1, "2017-01-09T05:00:00Z", null, "2017-01-09T14:50:09Z", "C1-2016-31670", 0, 0, "09000064824529dc"], ["FDA-2014-N-1205-0019", "FDA", "FDA-2014-N-1205", "Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems", "Rule", "Final Rule", "2016-12-30T05:00:00Z", 2016, 12, "2016-12-30T05:00:00Z", null, "2016-12-30T14:11:28Z", "2016-31670", 0, 0, "0900006482441325"], ["FDA-2014-N-1205-0027", "FDA", "FDA-2014-N-1205", "Reference 9 - DeIure 2012 Posterior lumbar fusion by peek rods in degenerative spine: preliminary report on 30 cases re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems", "Supporting & Related Material", "Background Material", "2016-12-30T05:00:00Z", 2016, 12, null, null, "2016-12-30T15:24:47Z", null, 0, 0, "0900006482441a70"], ["FDA-2014-N-1205-0028", "FDA", "FDA-2014-N-1205", "Reference  10 - Ormond 2016 Polyetheretherketone (PEEK) Rods in Lumbar Spine Degenerative Disease A Case Series re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems", "Supporting & Related Material", "Background Material", "2016-12-30T05:00:00Z", 2016, 12, null, null, "2016-12-30T15:24:50Z", null, 0, 0, "0900006482441a76"], ["FDA-2014-N-1205-0025", "FDA", "FDA-2014-N-1205", "Reference 7 - Athanasakopoulos 2013 Posterior Spinal Fusion Using Pedicle Screws re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems", "Supporting & Related Material", "Background Material", "2016-12-30T05:00:00Z", 2016, 12, null, null, "2016-12-30T15:24:41Z", null, 0, 0, "0900006482441a6d"], ["FDA-2014-N-1205-0030", "FDA", "FDA-2014-N-1205", "Reference  11 - Yang 2014 Short term outcome of posterior dynamic stabilization system in degenerative lumbar diseases re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems", "Supporting & Related Material", "Background Material", "2016-12-30T05:00:00Z", 2016, 12, null, null, "2016-12-30T15:24:57Z", null, 0, 0, "0900006482441a7a"], ["FDA-2014-N-1205-0024", "FDA", "FDA-2014-N-1205", "Reference 6 - Gornet 2011 Biomechanical Assessment of a PEEK Rod System for Semi-Rigid Fixation of Lumbar Fusion Constructs re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems", "Supporting & Related Material", "Background Material", "2016-12-30T05:00:00Z", 2016, 12, null, null, "2016-12-30T15:24:37Z", null, 0, 0, "0900006482441a6b"], ["FDA-2014-N-1205-0029", "FDA", "FDA-2014-N-1205", "Reference 10.1 - Ormond 2012 Polyetheretherketone (PEEK) Rods in Lumbar Spine Degenerative Disease: A Case Series re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems", "Supporting & Related Material", "Background Material", "2016-12-30T05:00:00Z", 2016, 12, null, null, "2016-12-30T15:24:53Z", null, 0, 0, "0900006482441a79"], ["FDA-2014-N-1205-0021", "FDA", "FDA-2014-N-1205", "Reference 3 - Qi 2013 Comparative effectiveness of PEEK rods versus titanium alloy rods in lumbar fusion: A preliminary report re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems", "Supporting & Related Material", "Background Material", "2016-12-30T05:00:00Z", 2016, 12, null, null, "2016-12-30T15:24:27Z", null, 0, 0, "0900006482441a68"], ["FDA-2014-N-1205-0022", "FDA", "FDA-2014-N-1205", "Reference 4 - Sengupta 2013 The Comprehensive Biomechanics and Load-Sharing of Semirigid PEEK and Semirigid Posterio Dynamic Stabilizations Systems re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems", "Supporting & Related Material", "Background Material", "2016-12-30T05:00:00Z", 2016, 12, null, null, "2016-12-30T15:24:30Z", null, 0, 0, "0900006482441a69"], ["FDA-2014-N-1205-0026", "FDA", "FDA-2014-N-1205", "Reference 8 - Colangeli 2015 Polyetheretherketone (PEEK) rods: short-term results in lumbar spine degenerative disease re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems", "Supporting & Related Material", "Background Material", "2016-12-30T05:00:00Z", 2016, 12, null, null, "2016-12-30T15:24:44Z", null, 0, 0, "0900006482441a6e"], ["FDA-2014-N-1205-0020", "FDA", "FDA-2014-N-1205", "Reference 1 - Matsuzaki 1990 Problems and Solutions of Pedicle Screw Plate Fixation of Lumbar Spine re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems", "Supporting & Related Material", "Background Material", "2016-12-30T05:00:00Z", 2016, 12, null, null, "2016-12-30T15:24:24Z", null, 0, 0, "0900006482441a67"], ["FDA-2014-N-1205-0023", "FDA", "FDA-2014-N-1205", "Reference 5 - Kurtz 2013 Retrieval analysis of PEEK rods for posterior fusion and motion preservation re Orthopedic Devices; Reclassification of Pedicle Screw Systems, Henceforth To Be Known as Thoracolumbosacral Pedicle Screw Systems, Including Semi-Rigid Systems", "Supporting & Related Material", "Background Material", "2016-12-30T05:00:00Z", 2016, 12, null, null, "2016-12-30T15:24:34Z", null, 0, 0, "0900006482441a6a"], ["FDA-2014-N-1205-0001", "FDA", "FDA-2014-N-1205", "Orthopedic Devices: Reclassification of Thoracolumbosacral Rigid Pedicle Screw Systems; Classification and Effective Date of Requirement for Premarket Approval for Dynamic Stabilization Systems", "Proposed Rule", "Advance Notice of Proposed Rulemaking (ANPRM)", "2014-11-12T05:00:00Z", 2014, 11, "2014-11-12T05:00:00Z", "2015-02-11T04:59:59Z", "2015-02-12T03:01:00Z", "2014-26726", 0, 0, "0900006481926d14"], ["FDA-2014-N-1205-0002", "FDA", "FDA-2014-N-1205", "List of Reference re Orthopedic Devices; Reclassification of Thoracolumbosacral Rigid Pedicle Screw Systems; Classification and Effective Date of Requirement for Premarket Approval for Dynamic Stabilization Systems", "Supporting & Related Material", "Background Material", "2014-11-12T05:00:00Z", 2014, 11, null, null, "2014-11-12T15:48:04Z", null, 0, 0, "09000064819279c4"], ["FDA-2014-N-1205-0003", "FDA", "FDA-2014-N-1205", "Reference 1- Circulatory System Devices Panel - 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