SeaSpine Orthopedics Corporation
Dispositifs autorisés FDA 510(k) et PMA — 67 produits
Publicité
Nombre total de dispositifs67
Catégories0
Dernière décision de la FDA
| Type | Numéro | Nom du dispositif | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy | MAX | 2026-07-01 | Voir |
| 510(k) | K250908 | Virata Spinal Fixation System | NKB | 2025-06-18 | Voir |
| 510(k) | K243659 | FLASH™ Facet Fusion Instruments, IsoTis® Facet Fusion Instruments | OLO | 2025-04-02 | Voir |
| 510(k) | K242273 | Cove Putty, OsteoCove Putty | MQV | 2024-09-25 | Voir |
| 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 | Voir |
| 510(k) | K240566 | Reef L Interbody System; WaveForm L Interbody System | MAX | 2024-04-26 | Voir |
| 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 | Voir |
| 510(k) | K233694 | Meridian Interbody System; WaveForm A Interbody System | MAX | 2024-01-12 | Voir |
| 510(k) | K233414 | Shoreline ACS Interbody System; Shoreline RT Interbody System | OVE | 2023-11-28 | Voir |
| 510(k) | K232668 | Cove Strip, OsteoCove Strip | MQV | 2023-09-27 | Voir |
| 510(k) | K231030 | Cove Putty, OsteoCove Putty | MQV | 2023-09-14 | Voir |
| 510(k) | K230486 | Cove Strip | MQV | 2023-08-21 | Voir |
| 510(k) | K220296 | Manta Ray TDF Spacer | ODP | 2023-02-03 | Voir |
| 510(k) | K222753 | SeaSpine 7D Navigation Instruments | OLO | 2022-12-09 | Voir |
| 510(k) | K222732 | WaveForm A Interbody System | MAX | 2022-11-07 | Voir |
| 510(k) | K222110 | Mariner RDX System | NKB | 2022-09-07 | Voir |
| 510(k) | K220711 | SeaSpine Meridian System, SeaSpine Meridian Anterior Plate System | MAX | 2022-05-10 | Voir |
| 510(k) | K213420 | WaveForm L System, WaveForm TO System, WaveForm TA System | MAX | 2022-05-04 | Voir |
| 510(k) | K212904 | SeaSpine WaveForm C Interbody System | OVE | 2021-12-14 | Voir |
| 510(k) | K213359 | SeaSpine WaveForm, C Interbody System | OVE | 2021-12-09 | Voir |
Aucun dispositif correspondant.