Atlas FDA

OSH

19 FDA 510(k) clearances · Product code

80 daysmedian time to decision
133 days90th percentile
19clearances measured

FDA profile

Official device name
Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3070
Medical specialty
Orthopedic
Flags
Implant
FDA definition
Intended to stabilize the thoracolumbar spine as an adjunct to fusion using allograft and/or autograft to treat adolescent idiopathic scoliosis.
Adverse events (MAUDE)
2016: 9 · 2018: 14 · 2019: 12 · 2020: 12 · 2023: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
OLYMPIC Posterior Spinal Fixation System (K153446)Astura Medical2016-04-08
CD HORIZON SPINAL SYSTEM (K140276)Medtronic Sofamor Danek2014-03-13
PASS LP SPINAL SYSTEM (K132574)Medicrea International2013-11-08
IMPLANET SPINE SYSTEM (K132303)Implanet, S.A.2013-10-10
PASS LP SPINAL SYSTEM (K132575)Medicrea International2013-10-03
EXPEDIUM, VIPER. VIPER 2 SPINE SYSTEM (K131802)Depuy Spine, A Johnson & Johnson Company2013-09-12
POLARIS SPINAL SYSTEM (K131615)Biomet Spine (Aka Ebi, LLC)2013-09-04
RANGE SPINAL SYSTEM (K131784)K2m, Inc.2013-08-30
CD HORIZON SPINAL SYSTEM (K131321)Medtronic Sofamor Danek USA2013-06-05
CREO STABILIZATION SYSTEM (K124058)Globus Medical, Inc.2013-05-13
RANGE SPINAL SYSTEM (K131030)K2m, Inc.2013-05-09
RESPONSE SPINE SYSTEM (K130655)OrthoPediatrics Corp.2013-05-08
RANGE SPINAL SYSTEM, SMALL STATURE (K122877)K2m, Inc.2013-05-08
RANGE SPINAL SYSTEM (K130330)K2m, Inc.2013-05-02
RANGE SPINAL SYSTEM, SMALL STRATURE COMPONENTS (K123412)K2m, Inc.2013-02-13
PASS LP SPINAL SYSTEM (K123138)Medicrea International2013-02-05
RANGE SPINAL SYSTEM (K121630)K2m, Inc.2012-09-11
OP SPINE SYSTEM (K121250)OrthoPediatrics Corp.2012-06-19
OP SPINE SYSTEM (K120291)OrthoPediatrics Corp.2012-04-16

Track OSH automatically

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