K7C SPACER— 510(k) K123388

Name: FDA 510(k) clearance K123388
Creator: U.S. Food and Drug Administration
Published: 2013-01-04

Substantially Equivalent

K7, LLC

FDA 510(k) clearance K123388 for K7C SPACER, Substantially Equivalent on 2013-01-04. Applicant: K7, LLC. Device class: 2.

Clearance details

Applicant: K7, LLC
Product code: Code ODP
Device class: Class 2
Regulation: 21 CFR 888.3080
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 ↗

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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.