FDA.reportPublic FDA data

510(k) K222732

Device
WaveForm A Interbody System
Applicant
SeaSpine Orthopedics Corporation
510(k) number
K222732
Product code
MAX
Decision
Substantially Equivalent (SESE)
Decision date
2022-11-07
Date received
2022-09-09
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Bone Graft, Lumbar
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jesse Albright
Address
5770 Armada Dr. Carlsbad CA US 92008 92008

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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510(k), Device, Applicant table
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K253266Titanium Interbody SystemSpine Innovation, LLC2026-01-08
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K252610ZSFab Lumbar Interbody SystemZsfab, Inc.2025-11-25
K252351UniSpace® TPLIF CageCg Medtech Co., Ltd.2025-10-28
K253377Expandable Titanium PLIF/TLIF SystemSpectrum Spine, Inc.2025-10-24