Data / Medical devices / United States / NanoHive Medical LLC
NanoHive Medical LLC: FDA-registered device maker in Woburn, MA, United States, 6 510(k) clearances
NanoHive Medical LLC is registered with the FDA (registration 3013462427) in Woburn, MA, United States. It lists 13 device types. The FDA files 6 510(k) clearances under its listings, the newest dated February 13, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013462427
- Address
- 12 Gill St Suite 4500, Woburn, MA, United States, 01801
- Owner or operator
- NanoHive Medical (10055679)
- Roles
- Manufacturer, Specification developer
- First device listed
- September 12, 2017
- Registered through
- 2026
- Brand names listed
- ALIF Hive-A Interbody Spacer, Bone Funnel, Drill Guide, HDLS Cervical IBFD System, Hammer, Hive AL Interbody System, Hive C Interbody System, Hive O-AL Interbody System and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 13, 2026 | K254105 | Hive Standalone Cervical System and Hive C Interbody System | ODP | Substantially Equivalent | NanoHive Medical, LLC | accessdata.fda.gov |
| July 12, 2023 | K231241 | NanoHive Medical Lumbar Interbody System | MAX | Substantially Equivalent | NanoHive Medical, LLC | accessdata.fda.gov |
| December 12, 2022 | K223190 | Hive Standalone Cervical System | OVE | Substantially Equivalent | NanoHive Medical, LLC | accessdata.fda.gov |
| April 28, 2020 | K200541 | Hive Stand-alone Anterior Lumbar Interbody System | OVD | Substantially Equivalent | Hd Lifesciences, LLC | accessdata.fda.gov |
| June 27, 2018 | K180364 | HD LifeSciences Cervical IBFD System | ODP | Substantially Equivalent | Hd Lifesciences, LLC | accessdata.fda.gov |
| July 13, 2017 | K170676 | HD Lumbar Interbody System | MAX | Substantially Equivalent | Hd Lifesciences, LLC | accessdata.fda.gov |
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Updated February 13, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.