FDA.reportPublic FDA data

510(k) K213196

Device
MARVEL? Growing Rods
Applicant
Globus Medical, Inc.
510(k) number
K213196
Product code
PGM
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-19
Date received
2021-09-29
Regulation
888.3070
Classification name
Growing Rod System
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kelly J. Baker
Address
2560 General Armistead Ave. Audubon PA US 19403 19403

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code PGM#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251961SDS Growing RodBAAT Medical Products B.V.2026-01-15
K241816VerteGlide Spinal Growth Guidance SystemOrthoPediatrics Corp.2025-03-14
K193224Daytona® Small Stature Growth Rod Conversion SetSeaSpine Orthopedics Corporation2020-02-13
K191212CrossOver 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 SystemMedos International SARL2019-09-24
K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.2018-06-29
K180227Polaris Spinal Growth SystemZimmer Biomet Spine, Inc.2018-03-15
K172979NuVasive® Growth Rod Conversion SetNu Vasive, Incorporated2017-11-06
K161028K2M Growing Spine SystemK2m, Inc.2016-07-22
K150200CD HORIZON Growth Rod Conversion SetMedtronic Sofamor Danek USA, Incorporated2015-02-25
K142114Xia® Growth Rod Conversion SetStryker Corporation2014-10-27
K141509ISOLA AND EXPEDIUM GROWING SPINE SYSTEMSMedos Sarl2014-08-22
K140750SHILLA GROWTH GUIDANCE SYSTEMMedtronic Sofamor Danek USA, Inc.2014-07-17
K133904CD HORIZON SPINAL SYSTEM GROWTH ROD SETMedtronic Sofamor Danek USA2014-02-25