BETACONE HIP PROSTHESIS SYSTEM— 510(k) K051826
Substantially EquivalentWaldemar Link GmbH & Co. KG
FDA 510(k) clearance K051826 for BETACONE HIP PROSTHESIS SYSTEM, Substantially Equivalent on 2005-11-18. Applicant: Waldemar Link GmbH & Co. KG.
Clearance details
- Applicant
- Waldemar Link GmbH & Co. KG
- Product code
- Code LWJ
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Philadelphia, PA, US
Adverse events under product code LWJ
product code LWJ- Injury
- 544
- Total
- 544
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.