PLAMP, PLAMP PLATE, PLAMP WITH HOOK— 510(k) K942032
Substantially Equivalent for Some IndicationsHospital For Special Surgery
FDA 510(k) clearance K942032 for PLAMP, PLAMP PLATE, PLAMP WITH HOOK, Substantially Equivalent for Some Indications on 1996-06-13. Applicant: Hospital For Special Surgery.
Clearance details
- Applicant
- Hospital For Special Surgery
- Product code
- Code HRS
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- New York, NY, US
Adverse events under product code HRS
product code HRS- Death
- 27
- Injury
- 10,340
- Malfunction
- 3,328
- Total
- 13,695
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.