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FDA 510(k)

Daytona® Small Stature Growth Rod Conversion Set

K-Number: K193224 · 2020-02-13

ApplicantSeaSpine Orthopedics Corporation
Decision Date2020-02-13
Product CodePGM
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Daytona® Small Stature Growth Rod Conversion Set is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2020-02-13 under approval number K193224. 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 Daytona® Small Stature Growth Rod Conversion Set?

Daytona® Small Stature Growth Rod Conversion Set is a medical device that received FDA 510(k) clearance on 2020-02-13. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K193224.

When was Daytona® Small Stature Growth Rod Conversion Set approved by the FDA?

Daytona® Small Stature Growth Rod Conversion Set received FDA 510(k) clearance on 2020-02-13, under approval number K193224.

What company makes Daytona® Small Stature Growth Rod Conversion Set?

Daytona® Small Stature Growth Rod Conversion Set is manufactured by SeaSpine Orthopedics Corporation.

What is the FDA product code for Daytona® Small Stature Growth Rod Conversion Set?

The FDA product code for Daytona® Small Stature Growth Rod Conversion Set is PGM.

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Related PubMed Literature

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Related Devices (Code: PGM)

K161028K2M Growing Spine SystemK2m, Inc. K172979NuVasive® Growth Rod Conversion SetNu Vasive, Incorporated 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 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.

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