PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-10016, 10018-10020— 510(k) K083619

Substantially Equivalent

Parcus Medical, LLC

FDA 510(k) clearance K083619 for PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-10016, 10018-10020, Substantially Equivalent on 2009-03-06. Applicant: Parcus Medical, LLC.

Clearance details

Applicant: Parcus Medical, LLC
Product code: Code HWC
Advisory panel: Orthopedic
Date received: 2008-12-08
Decision date: 2009-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sturgeon Bay, WI, US

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Adverse events under product code HWC

product code HWC

Death: 20
Injury: 15,910
Malfunction: 8,192
Other: 1
Total: 24,123

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.