SYNTHES SYNEX SPACER SYSTEM— 510(k) K003836

Substantially Equivalent

Synthes

FDA 510(k) clearance K003836 for SYNTHES SYNEX SPACER SYSTEM, Substantially Equivalent on 2001-05-29. Applicant: Synthes.

Clearance details

Applicant: Synthes
Product code: Code MQP
Advisory panel: Orthopedic
Date received: 2000-12-12
Decision date: 2001-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paoli, PA, US

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Adverse events under product code MQP

product code MQP

Injury: 372
Malfunction: 519
Total: 891

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.