NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI— 510(k) K884789
Substantially Equivalent for Some IndicationsProtek, Inc.
FDA 510(k) clearance K884789 for NEW JERSEY FEMORAL HIP PROSTHESIS FOR CEMENT APPLI, Substantially Equivalent for Some Indications on 1989-02-08. Applicant: Protek, Inc..
Clearance details
- Applicant
- Protek, Inc.
- Product code
- Code KWL
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent for Some Indications
- Clearance type
- Traditional
- Location
- Indianapolis, IN, US
Adverse events under product code KWL
product code KWL- Injury
- 523
- Total
- 523
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.