ENDOPROSTHESIS SYSTEM, VARIO-HEAD— 510(k) K781735
Substantially EquivalentWaldemar Link GmbH & Co. KG
FDA 510(k) clearance K781735 for ENDOPROSTHESIS SYSTEM, VARIO-HEAD, Substantially Equivalent on 1978-10-24. Applicant: Waldemar Link GmbH & Co. KG. Device class: 2.
Clearance details
- Applicant
- Waldemar Link GmbH & Co. KG
- Product code
- Code KWY
- Device class
- Class 2
- Regulation
- 21 CFR 888.3390
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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Adverse events under product code KWY
product code KWY- Death
- 3
- Injury
- 2,049
- Total
- 2,052
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.