RADIUS OSTEOTOMY PLATES— 510(k) K914804
Substantially Equivalent for Some IndicationsLink America, Inc.
FDA 510(k) clearance K914804 for RADIUS OSTEOTOMY PLATES, Substantially Equivalent for Some Indications on 1992-04-29. Applicant: Link America, Inc..
Clearance details
- Applicant
- Link America, Inc.
- Product code
- Code HRS
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- East Hanavor, NJ, 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.