SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM— 510(k) K964416

Substantially Equivalent for Some Indications

Synthes (Usa)

FDA 510(k) clearance K964416 for SYNTHES (U.S.A.)UNIVERSAL SPINAL PARELLEL CONNECTOR THE UNIVERSAL SPINAL ROD AND SCREW FIXATION SYSTEM, Substantially Equivalent for Some Indications on 1997-03-17. Applicant: Synthes (Usa).

Clearance details

Applicant: Synthes (Usa)
Product code: Code KWQ
Advisory panel: Orthopedic
Date received: 1996-10-04
Decision date: 1997-03-17
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Paoli, PA, US

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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.