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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 the device name listed in this FDA 510(k) record. The listed applicant is SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2020-02-13 under 510(k) 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. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K193224.

When did Daytona® Small Stature Growth Rod Conversion Set receive FDA 510(k) clearance?

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

Who is the listed applicant for Daytona® Small Stature Growth Rod Conversion Set?

The FDA 510(k) record lists SeaSpine Orthopedics Corporation as the applicant. This does not by itself establish the device manufacturer.

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 Devices (Code: PGM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251961SDS Growing RodBAAT Medical Products B.V.K241816VerteGlide Spinal Growth Guidance SystemOrthoPediatrics Corp.K213196MARVEL™ Growing RodsGlobus Medical, 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 SARLK181068CREO® Stabilization System, REVERE® Stabilization SystemGlobus Medical, Inc.K180227Polaris Spinal Growth SystemZimmer Biomet Spine, 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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