AXIOM TOTAL KNEE SYST, DUAL DOME ALL POLY TIB TRAY— 510(k) K930595
Substantially Equivalent for Some IndicationsOrthomet, Inc.
FDA 510(k) clearance K930595 for AXIOM TOTAL KNEE SYST, DUAL DOME ALL POLY TIB TRAY, Substantially Equivalent for Some Indications on 1993-10-22. Applicant: Orthomet, Inc..
Clearance details
- Applicant
- Orthomet, Inc.
- Product code
- Code JWH
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Minneapolis, MN, 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.