K873660
Substantially Equivalent for Some IndicationsROPER-TUKE ELBOW
- Applicant
- Orthopedic Systems, Inc.
- Product code
- JDB
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Hayward, CA, US
Adverse events under product code JDB
product code JDB- Injury
- 352
- Total
- 352
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.