Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian A
Summary
SeaSpine Orthopedics Corporation received 510(k) clearance 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, a MAX device. Cleared on 2026-07-01.
Details
Source
510(k) Clearance
External ID
K253420
Action Date
2026-07-01
Status
Traditional
Category
device
Product Code
MAX
Product Description
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. Product code: MAX.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 534 device clearances issued this month. SeaSpine Orthopedics Corporation has received 24 total clearances in our database.
SeaSpine Orthopedics Corporation has 33 FDA actions in our database, including 9 recalls and 24 clearances.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does SeaSpine Orthopedics Corporation have FDA actions?
SeaSpine Orthopedics Corporation has 33 FDA actions in our database, including 9 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K253420" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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