PLUS TOTAL KNEE SYSTEM, POLY TIBIAL PEG— 510(k) K875201
Substantially Equivalent for Some IndicationsOrthomet, Inc.
FDA 510(k) clearance K875201 for PLUS TOTAL KNEE SYSTEM, POLY TIBIAL PEG, Substantially Equivalent for Some Indications on 1988-02-17. 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.