id,agency_id,docket_id,title,document_type,subtype,posted_date,posted_year,posted_month,comment_start_date,comment_end_date,last_modified,fr_doc_num,open_for_comment,withdrawn,object_id
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,,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,,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,,,2016-12-30T15:24:47Z,,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,,,2016-12-30T15:24:50Z,,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,,,2016-12-30T15:24:41Z,,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,,,2016-12-30T15:24:57Z,,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,,,2016-12-30T15:24:37Z,,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,,,2016-12-30T15:24:53Z,,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,,,2016-12-30T15:24:27Z,,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,,,2016-12-30T15:24:30Z,,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,,,2016-12-30T15:24:44Z,,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,,,2016-12-30T15:24:24Z,,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,,,2016-12-30T15:24:34Z,,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,,,2014-11-12T15:48:04Z,,0,0,09000064819279c4
FDA-2014-N-1205-0003,FDA,FDA-2014-N-1205,Reference 1- Circulatory System Devices Panel - 2013 Meeting Materials of the Orthopaedic 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,,,2014-11-12T15:48:14Z,,0,0,09000064819279c5