SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEM— 510(k) K031276

Substantially Equivalent

Synthes (Usa)

FDA 510(k) clearance K031276 for SYNTHES ANTERIOR CERVICAL LOCKING PLATE (ACLP) SYSTEM, Substantially Equivalent on 2003-07-02. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 2003-04-22
Decision date: 2003-07-02
Decision: Substantially Equivalent
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.