MobileLink Acetabular Cup System - Line Extension (Multiple)— 510(k) K241636
Substantially EquivalentWaldemar Link GmbH & Co. KG
FDA 510(k) clearance K241636 for MobileLink Acetabular Cup System - Line Extension (Multiple), Substantially Equivalent on 2024-11-08. Applicant: Waldemar Link GmbH & Co. KG. Device class: 2.
Clearance details
- Applicant
- Waldemar Link GmbH & Co. KG
- Product code
- Code LPH
- Device class
- Class 2
- Regulation
- 21 CFR 888.3358
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norderstedt, DE
Recent devices under product code LPH
view allMore clearances from Waldemar Link GmbH & Co. KG
view allAdverse events under product code LPH
product code LPH- Death
- 73
- Injury
- 31,640
- Malfunction
- 3,358
- Other
- 2
- Total
- 35,073
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.