Hive Standalone Cervical System— 510(k) K223190

Name: FDA 510(k) clearance K223190
Creator: U.S. Food and Drug Administration
Published: 2022-12-12

Substantially Equivalent

NanoHive Medical, LLC

FDA 510(k) clearance K223190 for Hive Standalone Cervical System, Substantially Equivalent on 2022-12-12. Applicant: NanoHive Medical, LLC. Device class: 2.

Clearance details

Applicant: NanoHive Medical, LLC
Product code: Code OVE
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2022-10-13
Decision date: 2022-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code OVE

product code OVE

Injury: 293
Malfunction: 710
Total: 1,003

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.