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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 the device name listed in this FDA 510(k) record. The listed applicant is SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2021-12-09 under 510(k) 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. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K213359.

When did SeaSpine WaveForm, C Interbody System receive FDA 510(k) clearance?

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

Who is the listed applicant for SeaSpine WaveForm, C Interbody System?

The FDA 510(k) record lists SeaSpine Orthopedics Corporation as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing SeaSpine Orthopedics Corporation as applicant

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Related Devices (Code: OVE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261451ZSAlign Cervical Interbody SystemZSFab, Inc.K262094E3D™-C Interbody SystemEvolution SpineK261279DeltaNEC Interbody SystemNexus SpineK252982CONDUIT™ ZERO-P™ VA Secured Spacer SystemAvalign Technologies, Inc.K260036NeckTune™ 3D SA Cervical CageMedyssey Co, Ltd.K260660SABER-C SystemElevation Spine

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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