PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732— 510(k) K041117

Name: FDA 510(k) clearance K041117
Creator: U.S. Food and Drug Administration
Published: 2004-05-28

Substantially Equivalent

Depuy Mitek

FDA 510(k) clearance K041117 for PANALOK RC QUICKANCHOR PLUS, MODEL 212130, 212730; DUAL SUTURE PANALOK RC QUICKANCHOR PLLUS, MODELS 212132, 212732, Substantially Equivalent on 2004-05-28. Applicant: Depuy Mitek. Device class: 2.

Clearance details

Applicant: Depuy Mitek
Product code: Product code JDR
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2004-04-29
Decision date: 2004-05-28
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.