SYNTHES(U.S.A.) ANTERIOR SPINAL PLATE— 510(k) K925351

Substantially Equivalent for Some Indications

Synthes (Usa)

FDA 510(k) clearance K925351 for SYNTHES(U.S.A.) ANTERIOR SPINAL PLATE, Substantially Equivalent for Some Indications on 1993-11-05. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 1992-10-22
Decision date: 1993-11-05
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Paoli, PA, US

Download summary PDF View on FDA.gov ↗

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.