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FDA 510(k)

WaveForm L System, WaveForm TO System, WaveForm TA System

K-Number: K213420 · 2022-05-04

ApplicantSeaSpine Orthopedics Corporation
Decision Date2022-05-04
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

WaveForm L System, WaveForm TO System, WaveForm TA System is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2022-05-04 under approval number K213420. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WaveForm L System, WaveForm TO System, WaveForm TA System?

WaveForm L System, WaveForm TO System, WaveForm TA System is a medical device that received FDA 510(k) clearance on 2022-05-04. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K213420.

When was WaveForm L System, WaveForm TO System, WaveForm TA System approved by the FDA?

WaveForm L System, WaveForm TO System, WaveForm TA System received FDA 510(k) clearance on 2022-05-04, under approval number K213420.

What company makes WaveForm L System, WaveForm TO System, WaveForm TA System?

WaveForm L System, WaveForm TO System, WaveForm TA System is manufactured by SeaSpine Orthopedics Corporation.

What is the FDA product code for WaveForm L System, WaveForm TO System, WaveForm TA System?

The FDA product code for WaveForm L System, WaveForm TO System, WaveForm TA System is MAX.

Related Clinical Trials

NCT03681262 Comparing Long-term Effectiveness of High Frequency and Burst Spinal Cord Stimulation ACTIVE_NOT_RECRUITING

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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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