Balanced Knee Revision System Trabecular Tibial Cone Augments— 510(k) K182085
Substantially EquivalentOrtho Development Corporation
FDA 510(k) clearance K182085 for Balanced Knee Revision System Trabecular Tibial Cone Augments, Substantially Equivalent on 2018-10-31. Applicant: Ortho Development Corporation.
Clearance details
- Applicant
- Ortho Development Corporation
- Product code
- Code JWH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Draper, UT, US
Adverse events under product code JWH
product code JWH- Death
- 26
- Injury
- 51,564
- Malfunction
- 9,725
- Other
- 9
- Total
- 61,324
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.