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FDA 510(k)

SeaSpine® Daytona® Small Stature Spinal System

K-Number: K163604 · 2017-03-09

ApplicantSeaSpine Orthopedics Corporation
Decision Date2017-03-09
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

SeaSpine® Daytona® Small Stature Spinal System is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2017-03-09 under approval number K163604. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SeaSpine® Daytona® Small Stature Spinal System?

SeaSpine® Daytona® Small Stature Spinal System is a medical device that received FDA 510(k) clearance on 2017-03-09. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K163604.

When was SeaSpine® Daytona® Small Stature Spinal System approved by the FDA?

SeaSpine® Daytona® Small Stature Spinal System received FDA 510(k) clearance on 2017-03-09, under approval number K163604.

What company makes SeaSpine® Daytona® Small Stature Spinal System?

SeaSpine® Daytona® Small Stature Spinal System is manufactured by SeaSpine Orthopedics Corporation.

What is the FDA product code for SeaSpine® Daytona® Small Stature Spinal System?

The FDA product code for SeaSpine® Daytona® Small Stature Spinal System is NKB.

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026) PMID: 41612341 Brain-computer interface commercialization. Journal of neuroengineering and rehabilitation (2026) PMID: 39726899 How to improve the mechanical safety of a novel spinal implant while saving costs and time. JOR spine (2024)

Other Devices by SeaSpine Orthopedics Corporation

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Related Devices (Code: NKB)

K163301CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, Inc. K162134ENNOVATE Spinal SystemAesculap Implant Systems, LLC K162912VIPER PRIME™ additions to the VIPER® SystemMedos International SARL K162160Preference Elite Pedicle Screw SystemAmedica Corporation K162232MOSS 100 Pedicle Screw SystemBiedermann Motech GmbH & Co. KG K162379CD HORIZON® Spinal SystemMedtronic Sofamor Danek USA, 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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