Decision Date2017-11-06
Product CodePGM
Advisory CommitteeOR
DecisionSubstantially Equivalent
Device Summary
NuVasive® Growth Rod Conversion Set is a medical device manufactured by Nu Vasive, Incorporated. It received FDA 510(k) clearance on 2017-11-06 under approval number K172979. The device is classified under product code PGM. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the NuVasive® Growth Rod Conversion Set?
NuVasive® Growth Rod Conversion Set is a medical device that received FDA 510(k) clearance on 2017-11-06. It is manufactured by Nu Vasive, Incorporated. The 510(k) number is K172979.
When was NuVasive® Growth Rod Conversion Set approved by the FDA?
NuVasive® Growth Rod Conversion Set received FDA 510(k) clearance on 2017-11-06, under approval number K172979.
What company makes NuVasive® Growth Rod Conversion Set?
NuVasive® Growth Rod Conversion Set is manufactured by Nu Vasive, Incorporated.
What is the FDA product code for NuVasive® Growth Rod Conversion Set?
The FDA product code for NuVasive® Growth Rod Conversion Set is PGM.
Related Devices (Code: PGM)
K161028K2M Growing Spine SystemK2m, Inc.
K181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.
K180227Polaris Spinal Growth SystemZimmer Biomet Spine, Inc.
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 SARL
K193224Daytona® Small Stature Growth Rod Conversion SetSeaSpine Orthopedics Corporation
K213196MARVEL Growing RodsGlobus Medical, Inc.
Official Source
View on FDA Database →
Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.