POLY-TAPES WITH THE FASTLOK FIXATION DEVICE— 510(k) K010051

Substantially Equivalent

Xiros Plc

FDA 510(k) clearance K010051 for POLY-TAPES WITH THE FASTLOK FIXATION DEVICE, Substantially Equivalent on 2001-07-13. Applicant: Xiros Plc.

Clearance details

Applicant: Xiros Plc
Product code: Code JDR
Advisory panel: Orthopedic
Date received: 2001-01-08
Decision date: 2001-07-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Leeds, GB

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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.