Mariner Cap System— 510(k) K201240

Name: FDA 510(k) clearance K201240
Creator: U.S. Food and Drug Administration
Published: 2020-08-05

Substantially Equivalent

SeaSpine Orthopedics Corporation

FDA 510(k) clearance K201240 for Mariner Cap System, Substantially Equivalent on 2020-08-05. Applicant: SeaSpine Orthopedics Corporation. Device class: 2.

Clearance details

Applicant: SeaSpine Orthopedics Corporation
Product code: Code OWI
Device class: Class 2
Regulation: 21 CFR 888.3010
Advisory panel: Orthopedic
Date received: 2020-05-08
Decision date: 2020-08-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code OWI

view all

K261374 — LigaPASS System2026-05-27
K253615 — Invictus Bands System2026-03-25
K222097 — OLYMPIC Deformity Band System2023-05-04
K230565 — HILINE Fixation System2023-04-20
K213659 — LigaPASS 2.0 Ligament Augmentation System2022-05-24

More clearances from SeaSpine Orthopedics Corporation

view all

K253420 — Admiral ACP System +18 more2026-07-01
K250908 — Virata Spinal Fixation System2025-06-18
K243659 — FLASH Facet Fusion Instruments, IsoTis® Facet Fusion Instruments2025-04-02
K242273 — Cove Putty, OsteoCove Putty2024-09-25
K241466 — Shoreline ACS Interbody System +10 more2024-06-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.