FDA 510(k)

Exceed Biplanar Expandable Interbody System

K-Number: K231275 · 2023-07-25

Decision Date2023-07-25

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Exceed Biplanar Expandable Interbody System is a medical device manufactured by Spine Wave, Inc.. It received FDA 510(k) clearance on 2023-07-25 under approval number K231275. 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 Exceed Biplanar Expandable Interbody System?

Exceed Biplanar Expandable Interbody System is a medical device that received FDA 510(k) clearance on 2023-07-25. It is manufactured by Spine Wave, Inc.. The 510(k) number is K231275.

When was Exceed Biplanar Expandable Interbody System approved by the FDA?

Exceed Biplanar Expandable Interbody System received FDA 510(k) clearance on 2023-07-25, under approval number K231275.

What company makes Exceed Biplanar Expandable Interbody System?

Exceed Biplanar Expandable Interbody System is manufactured by Spine Wave, Inc..

What is the FDA product code for Exceed Biplanar Expandable Interbody System?

The FDA product code for Exceed Biplanar Expandable 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 NCT00453505 Modulation of Motor Function by Stimulation of the Central and Peripheral Nervous System COMPLETED NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT07254351 Analysis of the Biomechanical Impact of Lower Limb Length Inequality in PEDiatrics RECRUITING NCT07082426 Early System Experience With the Abbott Balloon-expandable TAVI System: First-In-Human Study ACTIVE_NOT_RECRUITING

Other Devices by Spine Wave, Inc.

K161993Leva® Anterior Interbody System K153222Leva Spacer System K160003Sniper (R) Spine System K152620Spine Wave Gen II Expandable Interbody System K172594Proficient® Posterior Cervical Spine System K173175Paramount Anterior Cervical Cage System

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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.