MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU— 510(k) K860133

Substantially Equivalent for Some Indications

Depuy, Inc.

FDA 510(k) clearance K860133 for MODIFIED SYNATOMIC VARIABLE FIT TIBIAL PLATEAU, Substantially Equivalent for Some Indications on 1986-03-10. Applicant: Depuy, Inc..

Clearance details

Applicant: Depuy, Inc.
Product code: Code HRY
Advisory panel: Orthopedic
Date received: 1986-01-14
Decision date: 1986-03-10
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Warsaw, IN, US

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Adverse events under product code HRY

product code HRY

Injury: 1,551
Malfunction: 2,753
Total: 4,304

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.