FDA.reportPublic FDA data

510(k) K161993

Device
Leva® Anterior Interbody System
Applicant
Spine Wave, Inc.
510(k) number
K161993
Product code
OVD  
Decision
Substantially Equivalent (SESE)
Decision date
2016-11-22
Date received
2016-07-19
Regulation
888.3080
Classification name
Intervertebral Fusion Device With Integrated Fixation, Lumbar
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Sanja Jahr
Address
3 Enterprise Dr. Suite 210 Shelton CT US 06484 06484

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code OVD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K254202MectaLIF 3D Metal AnteriorMedacta International S.A.2026-05-05
K253401SCRIPT™ Implant SystemGlobus Medical, Inc.2026-04-29
K253559Ventana™ A Anterior Lumbar Interbody SystemSpinal Elements, Inc.2026-02-25
K251829DeGen Medical Patient Specific Implant (PSI) SystemDegen Medical2025-12-08
K251575IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interbody SystemAlphatec Spine2025-09-03
K250072CONDUIT™ SYNFIX™ Evolution Secured Spacer SystemAvalign Technologies, Inc.2025-07-10
K251644ProAM ALIF SystemPro Surgical, Inc.2025-06-24
K250845Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.2025-06-18
K251459OneLIF™ Interbody Fusion SystemNovapproach Spine, LLC2025-06-12
K243934Stable-L Lumbar Interbody SystemNexus Spine, LLC2025-04-30
K243386Ventris Intervertebral Body Fusion DeviceAcuity Surgical Devices, LLC2025-04-22
K250603AxTiHA® Stand-Alone ALIF SystemInnovasis2025-03-24
K243802aprevo® anterior and lateral lumbar interbody fusion device, aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.2025-03-17
K243635aprevo® anterior lumbar interbody fusion device with interfixationCarlsmed, Inc.2024-12-13
K243191Atlas Spine Lateral Expandable Interbody SystemAtlas Spine, Inc.2024-11-26

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases