UNI-KNEE COMPONENT OF THE NATURAL-KNEE SYSTEM— 510(k) K883969
Substantially Equivalent for Some IndicationsIntermedics Orthopedics
FDA 510(k) clearance K883969 for UNI-KNEE COMPONENT OF THE NATURAL-KNEE SYSTEM, Substantially Equivalent for Some Indications on 1989-04-19. Applicant: Intermedics Orthopedics.
Clearance details
- Applicant
- Intermedics Orthopedics
- Product code
- Code HRY
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Austin, TX, 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.