PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHOR— 510(k) K063273

Substantially Equivalent

Depuy Miltek, A Johnson & Johnson Co.

FDA 510(k) clearance K063273 for PANALOK QUICKANCHOR PLUS, PANALOK RC QUICKANCHOR PLUS DUAL SUTURE, PANALOK ANCHOR, Substantially Equivalent on 2006-11-22. Applicant: Depuy Miltek, A Johnson & Johnson Co..

Clearance details

Applicant: Depuy Miltek, A Johnson & Johnson Co.
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 2006-10-30
Decision date: 2006-11-22
Decision: Substantially Equivalent
Clearance type: Special
Location: Raynham, MA, US

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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.