FDA 510(k)

SeaSpine WaveForm A Interbody System

K-Number: K210583 · 2021-06-02

ApplicantSeaSpine Orthopedics Corporation

Decision Date2021-06-02

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SeaSpine WaveForm A Interbody System is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2021-06-02 under approval number K210583. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SeaSpine WaveForm A Interbody System?

SeaSpine WaveForm A Interbody System is a medical device that received FDA 510(k) clearance on 2021-06-02. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K210583.

When was SeaSpine WaveForm A Interbody System approved by the FDA?

SeaSpine WaveForm A Interbody System received FDA 510(k) clearance on 2021-06-02, under approval number K210583.

What company makes SeaSpine WaveForm A Interbody System?

SeaSpine WaveForm A Interbody System is manufactured by SeaSpine Orthopedics Corporation.

What is the FDA product code for SeaSpine WaveForm A Interbody System?

The FDA product code for SeaSpine WaveForm A Interbody System is MAX.

Related Clinical Trials

NCT07222787 Post-market Safety and Effectiveness of the CORUS-LX System in Improving Lumbar Interbody Fusion Outcomes RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT03681262 Comparing Long-term Effectiveness of High Frequency and Burst Spinal Cord Stimulation ACTIVE_NOT_RECRUITING

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Related Devices (Code: MAX)

K163180Hubble IIOrbbo Surgical, LLC K162446FORZA Spacer System, PILLAR PEEK Spacer System, PILLAR SA PEEK Spacer System, SKYHAWK Lateral Interbody Fusion SystemOrthofix, Inc. K162327COUGAR® LS Lateral Cage System and COUGAR® SystemMedos International SARL K162103Choice Spine Lumbar Spacer System (Sabre, Shark, Hornet, Harpoon), Choice Spine Interbody Fusion System (Harrier), Choice Spine Vertebral Body Replacement System (Hawkeye)Choicespine, LP K162431Luna 3D Interbody Fusion SystemBenvenue Medical, Inc. K160959Xsert Lumbar Expandable Interbody SystemX-Spine Systems, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.