MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS— 510(k) K001105

Substantially Equivalent

Depuyacromed

FDA 510(k) clearance K001105 for MOSS MIAMI 6.35MM ROD SYSTEM PEDICLE AND LAMINAR HOOKS, Substantially Equivalent on 2000-04-24. Applicant: Depuyacromed.

Clearance details

Applicant: Depuyacromed
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 2000-04-05
Decision date: 2000-04-24
Decision: Substantially Equivalent
Clearance type: Special
Location: Raynham, MA, US

Download summary PDF View on FDA.gov ↗

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.