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FDA 510(k)

SeaSpine Daytona Small Stature Spinal System

K-Number: K180686 · 2018-05-14

ApplicantSeaSpine Orthopedics Corporation
Decision Date2018-05-14
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 2018-05-14 under approval number K180686. 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 2018-05-14. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K180686.

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

SeaSpine Daytona Small Stature Spinal System received FDA 510(k) clearance on 2018-05-14, under approval number K180686.

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)

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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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