S.T.E.P. UNI-KNEE— 510(k) K940389
Substantially Equivalent for Some IndicationsS.T.E.P. Orthopaedics, Inc.
FDA 510(k) clearance K940389 for S.T.E.P. UNI-KNEE, Substantially Equivalent for Some Indications on 1995-01-19. Applicant: S.T.E.P. Orthopaedics, Inc..
Clearance details
- Applicant
- S.T.E.P. Orthopaedics, Inc.
- Product code
- Code HRY
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Waterford, WI, US
Adverse events under product code HRY
product code HRY- Injury
- 1,551
- Malfunction
- 2,753
- Total
- 4,304
Source: openFDA MAUDE database, through . 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.