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FDA 510(k)

Seaspine WaveForm C Interbody System

K-Number: K201073 · 2020-09-18

ApplicantSeaSpine Orthopedics Corporation
Decision Date2020-09-18
Product CodeOVE
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Seaspine WaveForm C Interbody System is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2020-09-18 under approval number K201073. The device is classified under product code OVE. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Seaspine WaveForm C Interbody System?

Seaspine WaveForm C Interbody System is a medical device that received FDA 510(k) clearance on 2020-09-18. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K201073.

When was Seaspine WaveForm C Interbody System approved by the FDA?

Seaspine WaveForm C Interbody System received FDA 510(k) clearance on 2020-09-18, under approval number K201073.

What company makes Seaspine WaveForm C Interbody System?

Seaspine WaveForm C Interbody System is manufactured by SeaSpine Orthopedics Corporation.

What is the FDA product code for Seaspine WaveForm C Interbody System?

The FDA product code for Seaspine WaveForm C Interbody System is OVE.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT03681262 Comparing Long-term Effectiveness of High Frequency and Burst Spinal Cord Stimulation ACTIVE_NOT_RECRUITING

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Related Devices (Code: OVE)

K162531STERISPINE CCSafe Orthopaedics K162944Irix-C Cervical Integrated Fusion SystemX-Spine Systems, Inc. K160313Xenco Medical Cervical Interbody SystemXenco Medical, LLC K161442NuVasive® CoRoent® Small Interlock™ SystemNu Vasive, Incorporated K161081SeaSpine Shoreline ACS - Anterior Cervical Standalone SystemSeaSpine Orthopedics Corporation K160066Pro-Link® Stand-Alone Cervical Spacer SystemLife 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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