MobileLink Acetabular Cup System - inhouse coatings— 510(k) K243927
Substantially EquivalentWaldemar Link GmbH & Co. KG
FDA 510(k) clearance K243927 for MobileLink Acetabular Cup System - inhouse coatings, Substantially Equivalent on 2025-05-16. Applicant: Waldemar Link GmbH & Co. KG. Device class: 2.
Clearance details
- Applicant
- Waldemar Link GmbH & Co. KG
- Product code
- Code LZO
- Device class
- Class 2
- Regulation
- 21 CFR 888.3353
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Norderstedt, DE
Recent devices under product code LZO
view allMore clearances from Waldemar Link GmbH & Co. KG
view all- K250375 — Allure Hip Stem and Intramedullary Plugs
- K241636 — MobileLink Acetabular Cup System - Line Extension (Multiple)
- K231445 — LINK Embrace Shoulder System - Reverse Configuration
- K222066 — LINK MobileLink Acetabular Cup System
- K230471 — LinkSymphoKnee Fixed Bearing Ultracongruent (FB UC) Articulating Surface
Adverse events under product code LZO
product code LZO- Death
- 17
- Injury
- 12,942
- Malfunction
- 1,756
- Total
- 14,715
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.