SYNTHES SPINAL IMPLANT SYSTEM— 510(k) K802462

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K802462 for SYNTHES SPINAL IMPLANT SYSTEM, Substantially Equivalent on 1980-12-16. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code KWP
Advisory panel: Orthopedic
Date received: 1980-10-08
Decision date: 1980-12-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.