LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE— 510(k) K211768
Substantially EquivalentWaldemar Link GmbH & Co. KG
FDA 510(k) clearance K211768 for LINK Endo-Model Knee System, Femoral Segments (Augments), UHMWPE, Substantially Equivalent on 2021-06-30. Applicant: Waldemar Link GmbH & Co. KG. Device class: 2.
Clearance details
- Applicant
- Waldemar Link GmbH & Co. KG
- Product code
- Code KRO
- Device class
- Class 2
- Regulation
- 21 CFR 888.3510
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Norderstedt, DE
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Adverse events under product code KRO
product code KRO- Death
- 19
- Injury
- 4,841
- Total
- 4,860
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.