WaveForm L System, WaveForm TO System, WaveForm TA System

Intervertebral Fusion Device With Bone Graft, Lumbar

SeaSpine Orthopedics Corporation

The following data is part of a premarket notification filed by Seaspine Orthopedics Corporation with the FDA for Waveform L System, Waveform To System, Waveform Ta System.

Pre-market Notification Details

• Device ID: K213420
• 510k Number: K213420
• Device Name: WaveForm L System, WaveForm TO System, WaveForm TA System
• Classification: Intervertebral Fusion Device With Bone Graft, Lumbar
• Applicant: SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008
• Contact: Aly Alvarez
• Correspondent: Jesse Albright; SeaSpine Orthopedics Corporation 5770 Armada Drive Carlsbad, CA 92008
• Product Code: MAX
• CFR Regulation Number: 888.3080 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-10-20
• Decision Date: 2022-05-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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