FDA.reportPublic FDA data

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
No

Applicant Contact#

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

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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