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FDA 510(k)

Spine Wave Gen II Expandable Interbody System

K-Number: K152620 · 2016-01-15

ApplicantSpine Wave, Inc.
Decision Date2016-01-15
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Spine Wave Gen II Expandable Interbody System is a medical device manufactured by Spine Wave, Inc.. It received FDA 510(k) clearance on 2016-01-15 under approval number K152620. 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 Spine Wave Gen II Expandable Interbody System?

Spine Wave Gen II Expandable Interbody System is a medical device that received FDA 510(k) clearance on 2016-01-15. It is manufactured by Spine Wave, Inc.. The 510(k) number is K152620.

When was Spine Wave Gen II Expandable Interbody System approved by the FDA?

Spine Wave Gen II Expandable Interbody System received FDA 510(k) clearance on 2016-01-15, under approval number K152620.

What company makes Spine Wave Gen II Expandable Interbody System?

Spine Wave Gen II Expandable Interbody System is manufactured by Spine Wave, Inc..

What is the FDA product code for Spine Wave Gen II Expandable Interbody System?

The FDA product code for Spine Wave Gen II 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 NCT05438719 MOTUS Total Joint Replacement Investigational Device Exemption Study ACTIVE_NOT_RECRUITING NCT07589023 A Retrospective Review: Outcomes of the REFLECT™ System for Idiopathic Scoliosis NOT_YET_RECRUITING NCT05762055 Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative Technology ENROLLING_BY_INVITATION NCT05489822 PMCF Study to Evaluate the VERTICALE® Cervical System in Spine Surgery According to Its Intended Use. TERMINATED NCT06631638 EMPHASYS Cup Positioning in THA With Non-Invasive Navigation (Velys Hip Navigation (VHN)) RECRUITING

Related PubMed Literature

PMID: 38273730 Ten-Year Risk of Recall of Novel Spine Devices. Spine (2024) PMID: 36074993 Reported Events Associated With Spine Robots: An Analysis of the Food and Drug Administration's Manufacturer and User Facility Device Experience Database. Global spine journal (2023)

Other Devices by Spine Wave, Inc.

K161993Leva® Anterior Interbody System K153222Leva Spacer System K160003Sniper (R) Spine System K172594Proficient® Posterior Cervical Spine System K173175Paramount Anterior Cervical Cage System K172175CapSure® PS System

View all 22 devices →

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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