FDA cleared the 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 from SeaSpine Orthopedics Corporation on Jul 1, 2026 under K253420, a traditional 510(k). The device falls under product code MAX, Intervertebral Fusion Device With Bone Graft, Lumbar, regulated at 21 CFR 888.3080 as a Class 2 device. The review panel was Orthopedic.
FDA logged the submission as received on Oct 1, 2025. The decision came 273 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.
This is the only decision on file for SeaSpine Orthopedics Corporation in the last 12 months of the tracker.
Questions & Answers
What did FDA clear under K253420?
K253420 is the FDA 510(k) for 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, submitted by SeaSpine Orthopedics Corporation. FDA's decision date was Jul 1, 2026, under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar).
Who makes the 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?
SeaSpine Orthopedics Corporation, based in Carlsbad, CA, is the applicant of record for K253420.
How long did the K253420 review take?
FDA received the submission on Oct 1, 2025 and issued its decision on Jul 1, 2026, 273 days later.