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Regulatory documents from Regulations.gov including rules, proposed rules, notices, and supporting materials.

Data license: Public Domain (U.S. Government data) · Data source: Federal Register API & Regulations.gov API

16 rows where docket_id = "FDA-2014-N-1205" sorted by posted_date descending

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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posted_date ▲ posted_year posted_month comment_start_date comment_end_date last_modified fr_doc_num open_for_comment withdrawn object_id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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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 None 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

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CREATE TABLE documents (
    id TEXT PRIMARY KEY,
    agency_id TEXT,
    docket_id TEXT REFERENCES dockets(id),
    title TEXT,
    document_type TEXT,
    subtype TEXT,
    posted_date TEXT,
    posted_year INTEGER,
    posted_month INTEGER,
    comment_start_date TEXT,
    comment_end_date TEXT,
    last_modified TEXT,
    fr_doc_num TEXT,
    open_for_comment INTEGER,
    withdrawn INTEGER,
    object_id TEXT
);
CREATE INDEX idx_docs_agency ON documents(agency_id);
CREATE INDEX idx_docs_docket ON documents(docket_id);
CREATE INDEX idx_docs_date ON documents(posted_date);
CREATE INDEX idx_docs_year ON documents(posted_year);
CREATE INDEX idx_docs_type ON documents(document_type);
CREATE INDEX idx_docs_frnum ON documents(fr_doc_num);
CREATE INDEX idx_docs_comment_end ON documents(comment_end_date) WHERE comment_end_date IS NOT NULL AND withdrawn = 0;