MODIFICATION TO STRYKER XCEL ANCHOR SYSTEM— 510(k) K041307

Substantially Equivalent

Stryker Endoscopy

FDA 510(k) clearance K041307 for MODIFICATION TO STRYKER XCEL ANCHOR SYSTEM, Substantially Equivalent on 2004-06-14. Applicant: Stryker Endoscopy.

Clearance details

Applicant: Stryker Endoscopy
Product code: Code MAI
Advisory panel: Orthopedic
Date received: 2004-05-17
Decision date: 2004-06-14
Decision: Substantially Equivalent
Clearance type: Special
Location: San Jose, CA, US

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Adverse events under product code MAI

product code MAI

Injury: 1,948
Malfunction: 8,580
Total: 10,528

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.