MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM— 510(k) K023388

Name: FDA 510(k) clearance K023388
Creator: U.S. Food and Drug Administration
Published: 2002-12-27

Substantially Equivalent

Mitek Worldwide

FDA 510(k) clearance K023388 for MITEK RAPIDLOC-PDS MENISCAL REPAIR SYSTEM, Substantially Equivalent on 2002-12-27. Applicant: Mitek Worldwide. Device class: 2.

Clearance details

Applicant: Mitek Worldwide
Product code: Code JDR
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2002-10-09
Decision date: 2002-12-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Norwood, MA, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code JDR

product code JDR

Injury: 726
Malfunction: 663
Other: 1
Total: 1,390

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.