FDA 510(k)

SeaSpine WaveForm, C Interbody System

N.º K: K213359 · 2021-12-09

SolicitanteSeaSpine Orthopedics Corporation

Fecha de decisión2021-12-09

Código de productoOVE

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

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.

Preguntas frecuentes

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.

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Otros registros que enlistan a SeaSpine Orthopedics Corporation como solicitante

K253420Sistema Admiral ACP; Sistema Explorer TO; Sistema de Laminoplastia; Espaciador TDF Manta Ray; Sistema Interbody Meridian; Sistema de Placa Anterior Meridian; Sistema Interbody L Reef; Sistema TO/TA Reef; Sistema Lateral Regatta; Sistema de Placa Lateral Regatta; Sistema Interbody ACS Shoreline; Placa TruProfile Entornada Shoreline; Sistema Interbody RT Shoreline; Malla Vu; Sistema Interbody A WaveForm; Sistema Interbody C WaveForm; Sistema Interbody L WaveForm; Sistema Interbody TA WaveForm; Sistema Interbody TO WaveForm K250908Virata Spinal Fixation System K243659FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments K242273Cove Putty, OsteoCove Putty K241466Shoreline ACS Interbody System; Shoreline RT Interbody System; Regatta Lateral System; Reef L Interbody System; Reef TO/TA System; Meridian Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TO Interbody System; WaveForm TA Interbody System; WaveForm A Interbody System K240566Reef L Interbody System; WaveForm L Interbody System

Ver todos los 67 dispositivos →

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Fuente oficial

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