LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters— 510(k) K200607
Substantially EquivalentWaldemar Link GmbH & Co. KG
FDA 510(k) clearance K200607 for LINK MobileLink® Acetabular Cup System - Dual Mobility Liners, and Shell/Insert Adapters, Substantially Equivalent on 2021-05-28. 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 all- K261009 — MobileLink Acetabular Cup System 40mm ID Inserts (various)
- K250375 — Allure Hip Stem and Intramedullary Plugs
- K243927 — MobileLink Acetabular Cup System - inhouse coatings
- K241636 — MobileLink Acetabular Cup System - Line Extension (Multiple)
- K231445 — LINK Embrace Shoulder System - Reverse Configuration
Adverse 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 →
Recalls naming K200607
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K200607.
Data sourced from openFDA. This site is unofficial and independent of the FDA.