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FDA 510(k)

SeaSpine WaveForm, C Interbody System

K-Number: K213359 · 2021-12-09

ApplicantSeaSpine Orthopedics Corporation
Decision Date2021-12-09
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 2021-12-09 under approval number K213359. 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 2021-12-09. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K213359.

When was SeaSpine WaveForm, C Interbody System approved by the FDA?

SeaSpine WaveForm, C Interbody System received FDA 510(k) clearance on 2021-12-09, under approval number K213359.

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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