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FDA 510(k)

WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System

K-Number: K201755 · 2020-12-15

ApplicantSeaSpine Orthopedics Corporation
Decision Date2020-12-15
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System is a medical device manufactured by SeaSpine Orthopedics Corporation. It received FDA 510(k) clearance on 2020-12-15 under approval number K201755. 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 WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System?

WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System is a medical device that received FDA 510(k) clearance on 2020-12-15. It is manufactured by SeaSpine Orthopedics Corporation. The 510(k) number is K201755.

When was WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System approved by the FDA?

WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System received FDA 510(k) clearance on 2020-12-15, under approval number K201755.

What company makes WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System?

WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System is manufactured by SeaSpine Orthopedics Corporation.

What is the FDA product code for WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA Interbody System?

The FDA product code for WaveForm L Interbody System, WaveForm TO Interbody System, WaveForm TA 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

View on FDA Database →

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

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