Klassic Femur, Porous, Klassic Tibial Baseplate, Porous— 510(k) K162256
Substantially EquivalentTotal Joint Orthopedics, Inc.
FDA 510(k) clearance K162256 for Klassic Femur, Porous, Klassic Tibial Baseplate, Porous, Substantially Equivalent on 2016-10-27. Applicant: Total Joint Orthopedics, Inc..
Clearance details
- Applicant
- Total Joint Orthopedics, Inc.
- Product code
- Code MBH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Salt Lake City, UT, US
Adverse events under product code MBH
product code MBH- Injury
- 6,545
- Malfunction
- 2,023
- Total
- 8,568
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.