SeaSpine Orthopedics Corporation
FDA 510(k) & PMA Approved Dispositivos — 67 products
Publicidad
Total de dispositivos67
Categorías0
Última decisión de la FDA
| Tipo | Número | Nombre del dispositivo | Código | Fecha | Acciones |
|---|---|---|---|---|---|
| 510(k) | K253420 | Sistema 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 | MAX | 2026-07-01 | Ver |
| 510(k) | K250908 | Virata Spinal Fixation System | NKB | 2025-06-18 | Ver |
| 510(k) | K243659 | FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments | OLO | 2025-04-02 | Ver |
| 510(k) | K242273 | Cove Putty, OsteoCove Putty | MQV | 2024-09-25 | Ver |
| 510(k) | K241466 | Shoreline 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 | MAX | 2024-06-20 | Ver |
| 510(k) | K240566 | Reef L Interbody System; WaveForm L Interbody System | MAX | 2024-04-26 | Ver |
| 510(k) | K232566 | NewPort Spinal System; Daytona Small Stature Spinal System; Malibu Spinal System; Mariner Pedicle Screw Systems: Mariner Outrigger Revision System; Mariner MIS Pedicle Screw System; Mariner Deformity System; Mariner RDX System | NKB | 2024-04-19 | Ver |
| 510(k) | K233694 | Meridian Interbody System; WaveForm A Interbody System | MAX | 2024-01-12 | Ver |
| 510(k) | K233414 | Shoreline ACS Interbody System; Shoreline RT Interbody System | OVE | 2023-11-28 | Ver |
| 510(k) | K232668 | Cove Strip, OsteoCove Strip | MQV | 2023-09-27 | Ver |
| 510(k) | K231030 | Cove Putty, OsteoCove Putty | MQV | 2023-09-14 | Ver |
| 510(k) | K230486 | Cove Strip | MQV | 2023-08-21 | Ver |
| 510(k) | K220296 | Manta Ray TDF Spacer | ODP | 2023-02-03 | Ver |
| 510(k) | K222753 | SeaSpine 7D Navigation Instruments | OLO | 2022-12-09 | Ver |
| 510(k) | K222732 | WaveForm A Interbody System | MAX | 2022-11-07 | Ver |
| 510(k) | K222110 | Mariner RDX System | NKB | 2022-09-07 | Ver |
| 510(k) | K220711 | SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System | MAX | 2022-05-10 | Ver |
| 510(k) | K213420 | WaveForm L System, WaveForm TO System, WaveForm TA System | MAX | 2022-05-04 | Ver |
| 510(k) | K212904 | SeaSpine WaveForm C Interbody System | OVE | 2021-12-14 | Ver |
| 510(k) | K213359 | SeaSpine WaveForm, C Interbody System | OVE | 2021-12-09 | Ver |
No hay dispositivos coincidentes.