Atlas FDA

PGM

14 FDA 510(k) clearances · Product code

84 daysmedian time to decision
263 days90th percentile
14clearances measured

FDA profile

Official device name
Growing Rod System
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3070
Medical specialty
Orthopedic
Flags
Implant
FDA definition
Stabilization or correction of spinal deformities without the use of fusion.
Adverse events (MAUDE)
2016: 9
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
SDS Growing Rod (K251961)BAAT Medical Products B.V.2026-01-15
VerteGlide Spinal Growth Guidance System (K241816)OrthoPediatrics Corp.2025-03-14
MARVEL™ Growing Rods (K213196)Globus Medical, Inc.2022-12-19
Daytona® Small Stature Growth Rod Conversion Set (K193224)SeaSpine Orthopedics Corporation2020-02-13
CrossOver Cross Connectors, DePuy PULSE Thoracolumbar Screw System, EXPEDIUM Fenestrated Screw System, EXPEDIUM SFX Cross Connectors, EXPEDIUM Spine System, EXPEDIUM VERSE Spine System, E-Z Link Cross Connectors, ISOLA Spine System, MONARCH Spine System, MOSS MIAMI Spine System, TiMX Low Back System, VIPER Fenestrated Screw System, VIPER PRIME System, VIPER PRIME Fenestrated Screws, VIPER SAI (Sacral-Alar-Iliac), VIPER System, VIPER 2 System, VSP Spine System (K191212)Medos International SARL2019-09-24
CREO® Stabilization System, REVERE® Stabilization System (K181068)Globus Medical, Inc.2018-06-29
Polaris Spinal Growth System (K180227)Zimmer Biomet Spine, Inc.2018-03-15
NuVasive® Growth Rod Conversion Set (K172979)Nu Vasive, Incorporated2017-11-06
K2M Growing Spine System (K161028)K2m, Inc.2016-07-22
CD HORIZON Growth Rod Conversion Set (K150200)Medtronic Sofamor Danek USA, Incorporated2015-02-25
Xia® Growth Rod Conversion Set (K142114)Stryker Corporation2014-10-27
ISOLA AND EXPEDIUM GROWING SPINE SYSTEMS (K141509)Medos Sarl2014-08-22
SHILLA GROWTH GUIDANCE SYSTEM (K140750)Medtronic Sofamor Danek USA, Inc.2014-07-17
CD HORIZON SPINAL SYSTEM GROWTH ROD SET (K133904)Medtronic Sofamor Danek USA2014-02-25

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