K7C SPACER— 510(k) K123388

Substantially Equivalent

K7, LLC

FDA 510(k) clearance K123388 for K7C SPACER, Substantially Equivalent on 2013-01-04. Applicant: K7, LLC.

Clearance details

Applicant: K7, LLC
Product code: Code ODP
Advisory panel: Orthopedic
Date received: 2012-11-02
Decision date: 2013-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chesterland, OH, US

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.