SOLITAIRE-C CERVICAL SPACER SYSTEM— 510(k) K113796

Substantially Equivalent

Ebi, LLC

FDA 510(k) clearance K113796 for SOLITAIRE-C CERVICAL SPACER SYSTEM, Substantially Equivalent on 2012-04-26. Applicant: Ebi, LLC.

Clearance details

Applicant: Ebi, LLC
Product code: Code OVE
Advisory panel: Orthopedic
Date received: 2011-12-23
Decision date: 2012-04-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parsippany, NJ, US

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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.