Atlas FDA

NQP

22 FDA 510(k) clearances · Product code

81 daysmedian time to decision
302 days90th percentile
22clearances measured

FDA profile

Official device name
Posterior Metal/Polymer Spinal System, Fusion
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3070
Medical specialty
Orthopedic
Flags
Implant
FDA definition
This device is a posterior spinal system that contains polymer and metal components. This spinal system is to be used with bone graft and is an adjunct to fusion in the treatment of acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine.
Adverse events (MAUDE)
2014: 46 · 2015: 38 · 2016: 79 · 2017: 28 · 2018: 29 · 2020: 15
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
CD HORIZON™ Spinal System (K203678)Medtronic Sofamor Danek USA, Inc.2021-01-15
CD Horizon™ Astute™ Spinal System (K191066)Medtronic Sofamor Danek USA, Inc.2019-10-03
CD Horizon™ Spinal System (K182928)Medtronic Sofamor Danek USA, Inc.2019-01-11
DYNESYS TOP-LOADING SPINAL SYSTEM (K133164)Zimmer Spine, Inc.2014-01-16
ZIMMER DTO PIN PRESS INSTRUMENT (K101704)Zimmer Spine, Inc.2010-08-18
DSS STABILIZATION SYSTEM (K101083)Paradigm Spine, LLC2010-07-02
DYNESYS TOP-LOADING SPINAL SYSTEM (K092234)Zimmer Spine, Inc.2009-10-01
MODIFICATION TO: DSS STABILIZATION SYSTEM (K091944)Paradigm Spine, LLC2009-08-03
TRANSITION STABILIZATION SYSTEM (K073439)Globus Medical, Inc.2009-02-20
DDS STABILIZATION SYSTEM (K080241)Paradigm Spine, LLC2008-11-28
DSS STABILIZATION SYSTEM (K080963)Paradigm Spine2008-05-02
ISOBAR SEMI-RIGID DUAL DAMPENER (K071261)Scient'X2008-04-17
BIOFLEX (K072321)Biospine Co., Ltd.2008-03-25
DYNESYS TOP-LOADING SPINAL SYSTEM (K073347)Zimmer Spine, Inc.2008-02-08
DSS (K072969)Paradigm Spine, LLC2008-01-24
NGARDE SYSTEM (K072685)N Spine, Inc.2007-10-19
ZIMMER DTO IMPLANT (K071879)Zimmer Spine, Inc.2007-10-05
NFIX II PEDICLE SCREW SYSTEM (K061774)N Spine, Inc.2006-12-13
CD HORIZON SPINAL SYSTEM (K061304)Medtronic Sofamor Danek2006-07-18
DYNESYS SPINAL SYSTEM WITH HA COATED SCREWS (K060638)Zimmer Spine, Inc.2006-04-06
MODIFICATION TO DYNESYS SPINAL SYSTEM (K043565)Zimmer Spine, Inc.2005-03-11
DYNESYS SPINAL SYSTEM (K031511)Centerpulse Spine-Tech, Inc.2004-03-05

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Every clearance here is in the API, with alerts when new ones post.