FDA 510(k)

Cove Putty, OsteoCove Putty

N.º K: K231030 · 2023-09-14

SolicitanteSeaSpine Orthopedics Corporation

Fecha de decisión2023-09-14

Código de productoMQV

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Cove Putty, OsteoCove Putty 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 2023-09-14 under 510(k) number K231030. The device is classified under product code MQV. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Cove Putty, OsteoCove Putty?

Cove Putty, OsteoCove Putty is a medical device that received FDA 510(k) clearance on 2023-09-14. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K231030.

When did Cove Putty, OsteoCove Putty receive FDA 510(k) clearance?

Cove Putty, OsteoCove Putty received FDA 510(k) clearance on 2023-09-14, under 510(k) number K231030.

Who is the listed applicant for Cove Putty, OsteoCove Putty?

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 Cove Putty, OsteoCove Putty?

The FDA product code for Cove Putty, OsteoCove Putty is MQV.

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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

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Dispositivos relacionados (Código: MQV)

Fuente oficial

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