MOSS MIAMI 6.35MM POLYAXIAL SCREW— 510(k) K992168

Substantially Equivalent

Depuyacromed

FDA 510(k) clearance K992168 for MOSS MIAMI 6.35MM POLYAXIAL SCREW, Substantially Equivalent on 1999-09-23. Applicant: Depuyacromed.

Clearance details

Applicant: Depuyacromed
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 1999-06-28
Decision date: 1999-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Raynham, MA, US

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Adverse events under product code KWQ

product code KWQ

Death: 8
Injury: 1,212
Malfunction: 1,233
Total: 2,453

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.