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FDA 510(k)

Hive™ Stand-alone Anterior Lumbar Interbody System

K-Number: K200541 · 2020-04-28

ApplicantHd Lifesciences, LLC
Decision Date2020-04-28
Product CodeOVD
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Hive™ Stand-alone Anterior Lumbar Interbody System is the device name listed in this FDA 510(k) record. The listed applicant is Hd Lifesciences, LLC. It received FDA 510(k) clearance on 2020-04-28 under 510(k) number K200541. The device is classified under product code OVD. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Hive™ Stand-alone Anterior Lumbar Interbody System?

Hive™ Stand-alone Anterior Lumbar Interbody System is a medical device that received FDA 510(k) clearance on 2020-04-28. The listed applicant is Hd Lifesciences, LLC. The 510(k) number is K200541.

When did Hive™ Stand-alone Anterior Lumbar Interbody System receive FDA 510(k) clearance?

Hive™ Stand-alone Anterior Lumbar Interbody System received FDA 510(k) clearance on 2020-04-28, under 510(k) number K200541.

Who is the listed applicant for Hive™ Stand-alone Anterior Lumbar Interbody System?

The FDA 510(k) record lists Hd Lifesciences, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Hive™ Stand-alone Anterior Lumbar Interbody System?

The FDA product code for Hive™ Stand-alone Anterior Lumbar Interbody System is OVD.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT05762055Prospective Comparative Analysis of ACDF vs Fusion Interbody Cages With nanoLOCK Osseointegrative TechnologyENROLLING_BY_INVITATIONNCT06462729LDGraft in Single Level Anterior Lumbar Interbody Fusion (ALIF)RECRUITING

Other records listing Hd Lifesciences, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K180364HD LifeSciences Cervical IBFD SystemK170676HD Lumbar Interbody System

Related Devices (Code: OVD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261408SABER-XA SystemElevation SpineK261809Interwedge® Standalone LateralFoundation Surgical GroupK261353Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar Anchor SystemKyocera Medical Technologies, Inc.K260810Anteralign LS coverplateTyber Medical, LLCK254202MectaLIF 3D Metal AnteriorMedacta International S.A.K253401SCRIPT™ Implant SystemGlobus Medical, 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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