FDA.report

510(k) K200541

Device
Hive™ Stand-alone Anterior Lumbar Interbody System
Applicant
Hd Lifesciences, LLC
510(k) number
K200541
Product code
OVD
Decision
Substantially Equivalent (SESE)
Decision date
2020-04-28
Date received
2020-03-03
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
N
Source
FDA openFDA 510(k) dataset plus migrated FDA.report data

Related Records

Applicant Contact

Contact
John Sullivan
Address
12 Gill St., Suite 4500 Woburn MA US 01801 01801

FDA Registration Numbers

Source Documents

FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON

Related GUDID Devices

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00817493024051Hive Standalone ALIF SystemNanohive Medical LLC2023-08-31
00817493024150Hive Standalone ALIF SystemNanohive Medical LLC2023-08-31
00817493024143Hive Standalone ALIF SystemNanohive Medical LLC2023-08-31
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00817493024099Hive Standalone ALIF SystemNanohive Medical LLC2023-08-31
00817493024082Hive Standalone ALIF SystemNanohive Medical LLC2023-08-31
00817493024068Hive Standalone ALIF SystemNanohive Medical LLC2023-08-31
00817493024167Hive Standalone ALIF SystemNanohive Medical LLC2023-08-31
00817493024044Hive Standalone ALIF SystemNanohive Medical LLC2023-08-31
00817493024037Hive Standalone ALIF SystemNanohive Medical LLC2023-08-31
00817493023993Hive Standalone ALIF SystemNanohive Medical LLC2023-08-31

Other 510(k) Records For Product Code OVD

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K254202MectaLIF 3D Metal AnteriorMedacta International S.A.2026-05-05
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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