FDA 510(k)

Daytona® Small Stature Growth Rod Conversion Set

N.º K: K193224 · 2020-02-13

SolicitanteSeaSpine Orthopedics Corporation

Fecha de decisión2020-02-13

Código de productoPGM

Comité asesorOR

DecisiónSubstantially Equivalent

Resumen del dispositivo

Daytona® Small Stature Growth Rod Conversion Set 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 2020-02-13 under 510(k) number K193224. The device is classified under product code PGM. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Daytona® Small Stature Growth Rod Conversion Set?

Daytona® Small Stature Growth Rod Conversion Set is a medical device that received FDA 510(k) clearance on 2020-02-13. The listed applicant is SeaSpine Orthopedics Corporation. The 510(k) number is K193224.

When did Daytona® Small Stature Growth Rod Conversion Set receive FDA 510(k) clearance?

Daytona® Small Stature Growth Rod Conversion Set received FDA 510(k) clearance on 2020-02-13, under 510(k) number K193224.

Who is the listed applicant for Daytona® Small Stature Growth Rod Conversion Set?

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 Daytona® Small Stature Growth Rod Conversion Set?

The FDA product code for Daytona® Small Stature Growth Rod Conversion Set is PGM.

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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: PGM)

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.