LINK CEMENTLESS SCREW-IN ACETABULAR CUP— 510(k) K843950
Substantially EquivalentWaldemar Link GmbH & Co. KG
FDA 510(k) clearance K843950 for LINK CEMENTLESS SCREW-IN ACETABULAR CUP, Substantially Equivalent on 1985-06-03. Applicant: Waldemar Link GmbH & Co. KG. Device class: 3.
Clearance details
- Applicant
- Waldemar Link GmbH & Co. KG
- Product code
- Code KWA
- Device class
- Class 3
- Regulation
- 21 CFR 888.3330
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- E. Hanover, NJ, US
Recent devices under product code KWA
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 KWA
product code KWA- Death
- 38
- Injury
- 10,439
- Malfunction
- 1,862
- Total
- 12,339
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.