NanoHive Medical LLC
Woburn, MA, US
NanoHive Medical LLC appears in FDA device records in Woburn, MA. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for NanoHive Medical LLC between 2022 and 2026. The busiest year on record is 2022, with 1. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2022 | 1 |
| 2023 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K254105 | Hive™ Standalone Cervical System and Hive™ C Interbody System | ODP | Substantially Equivalent | |
| K231241 | NanoHive Medical Lumbar Interbody System | MAX | Substantially Equivalent | |
| K223190 | Hive™ Standalone Cervical System | OVE | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013462427 | 3013462427 | NanoHive Medical LLC | 12 Gill St, Woburn, MA 01801 US | 2026 | and 3 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HWJAwl
- HTWBit, Drill
- FZXGuide, Surgical, Instrument
- HWAImpactor
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- HXLMallet
- LXHOrthopedic Manual Surgical Instrument
- HTRRasp
- HXXScrewdriver
- FSMTray, Surgical, Instrument
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain