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

Clearance details

Applicant

Depuy, Inc.

Product code

Code HRY

Device class

Class 2

Regulation

21 CFR 888.3530

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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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 →