LINK Embrace Shoulder System- Anatomical Configuration— 510(k) K210899
Substantially EquivalentWaldemar Link GmbH & Co. KG
FDA 510(k) clearance K210899 for LINK Embrace Shoulder System- Anatomical Configuration, Substantially Equivalent on 2021-06-21. Applicant: Waldemar Link GmbH & Co. KG.
Clearance details
- Applicant
- Waldemar Link GmbH & Co. KG
- Product code
- Code KWT
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norderstedt, DE
Adverse events under product code KWT
product code KWT- Injury
- 2,467
- Other
- 2
- Total
- 2,469
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.