POROSTEON PHUSION METAL CERVICAL CAGE— 510(k) K142041

Substantially Equivalent

Porosteon, Inc.

FDA 510(k) clearance K142041 for POROSTEON PHUSION METAL CERVICAL CAGE, Substantially Equivalent on 2014-12-19. Applicant: Porosteon, Inc..

Clearance details

Applicant: Porosteon, Inc.
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2014-07-28
Decision date: 2014-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Notre-Dame-De-L'Lle-Perrot,Quebec, CA

Download summary PDF View on FDA.gov ↗

Adverse events under product code ODP

product code ODP

Injury: 310
Total: 310

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.