5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM)— 510(k) K022623

Substantially Equivalent

Depuyacromed

FDA 510(k) clearance K022623 for 5.0 MM DIAMETER POLYAXIAL SCREWS (MOSS MIAMI 6.35MM SYSTEM), Substantially Equivalent on 2002-08-27. Applicant: Depuyacromed.

Clearance details

Applicant: Depuyacromed
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 2002-08-07
Decision date: 2002-08-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Raynham, MA, US

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Adverse events under product code KWP

product code KWP

Death: 7
Injury: 1,539
Malfunction: 1,519
Total: 3,065

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.