Growing Rod System
Orthopedic · 21 CFR 888.3070
Stabilization or correction of spinal deformities without the use of fusion.
Recent MDR events
43 adverse event reports on file
- VERTEGLIDE¿ 4.5 OPEN SET SCREW ASSEMBLYJul 21, 2026MalfunctionOrthopediatrics3006460162-2026-00035
- MARVELJul 16, 2026MalfunctionGlobus Medical, Inc.3004142400-2026-00153
- MARVELApr 7, 2026MalfunctionGlobus Medical, Inc.3004142400-2026-00071
- MARVELApr 3, 2026MalfunctionGlobus Medical, Inc.3004142400-2026-00069
- MARVELMar 20, 2026MalfunctionGlobus Medical, Inc.3004142400-2026-00068
- VERTEGLIDE¿ 4.5 POLYAXIAL PEDICLE SCREW 4.5MM X 30MM, CLOSEDMar 3, 2026MalfunctionOrthopediatrics3006460162-2026-00010
- SHILLA GROWTH GUIDANCE SYSTEMDec 30, 2025InjuryMedtronic Sofamor Danek Usa, Inc.3003120897-2025-00823
- CD HORIZON® GROWTH ROD CONVERSION SETApr 22, 2025MalfunctionWarsaw Orthopedics1030489-2025-01789
- CD HORIZON® GROWTH ROD CONVERSION SETApr 22, 2025MalfunctionWarsaw Orthopedics1030489-2025-01790
- CD HORIZON® GROWTH ROD CONVERSION SETApr 22, 2025MalfunctionWarsaw Orthopedics1030489-2025-01791
Event type breakdown
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
53 firms currently registered for this product code
B & J Medical Llc
Kendallville, IN, US
J&b Precision, Inc.
Cordova, TN, US
Medtronic Sofamor Danek Usa, Inc.
Memphis, TN, US
Frueh Verpackungstechnik Ag
Fehraltorf Zurich, CH
Olive Branch Distribution Center
Olive Branch, MS, US
Synthes Gmbh
Selzach Solothurn, CH
Synthes Gmbh
Zuchwil Solothurn, CH
Nuvasive, Inc.
Guaynabo, PR, US
Arch - Quakertown
QUAKERTOWN, PA, US
Globus Medical, Inc.
AUDUBON, PA, US
Stryker Spine
ALLENDALE, NJ, US
Culver Tool & Engineering
Plymouth, IN, US
Depuy Spine, Inc.
RAYNHAM, MA, US
Harwood Design, Inc.
Bristol, PA, US
Exel Inc. Dba Dhl Supply Chain (usa)
Mooresville, IN, US
Globus Medical, Inc.
Memphis, TN, US
Depuy Orthopaedics
BRIDGEWATER, MA, US
Fmi Medisch Bv
Schiedam Zuid-Holland, NL
W+s Solutions Gmbh
Tuttlingen Baden-Wurttemberg, DE
Vorzeigen
Connersville, IN, US
Inomed Technology Sa
Courtelary Bern, CH
Rms Co.
MINNEAPOLIS, MN, US
510(k) clearances
14 clearances for this product code
- BAAT Medical Products B.V.Jan 15, 2026
K251961 · SDS Growing Rod
- OrthoPediatrics Corp.Mar 14, 2025
K241816 · VerteGlide Spinal Growth Guidance System
- Globus Medical, Inc.Dec 19, 2022
K213196 · MARVEL Growing Rods
- SeaSpine Orthopedics CorporationFeb 13, 2020
K193224 · Daytona® Small Stature Growth Rod Conversion Set
- Medos International SARLSep 24, 2019
K191212 · 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
- Globus Medical, Inc.Jun 29, 2018
K181068 · CREO® Stabilization System, REVERE® Stabilization System
- Zimmer Biomet Spine, Inc.Mar 15, 2018
K180227 · Polaris Spinal Growth System
- Nu Vasive, IncorporatedNov 6, 2017
K172979 · NuVasive® Growth Rod Conversion Set