Admiral ACP System +18 more— 510(k) K253420

Clearance details

Device name as filed

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

Applicant

SeaSpine Orthopedics Corporation

Product code

Code MAX

Device class

Class 2

Regulation

21 CFR 888.3080

Advisory panel

Orthopedic

Date received

2025-10-01

Decision date

2026-07-01

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Carlsbad, CA, US

• K261049 — SCALA® TL2026-08-20
• K261430 — TruLift Expandable System2026-07-28
• K253011 — Catalyft PL Expandable Interbody System2026-07-17
• K261020 — Symmetrix L Spinal System2026-07-14
• K253151 — Fule Interbody Fusion Cage System2026-06-15

• 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
• K240566 — Reef L Interbody System; WaveForm L Interbody System2024-04-26

Death

13

Injury

1,305

Malfunction

2,885

Total

4,203

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →