MobileLink Acetabular Cup System 40mm ID Inserts (various)— 510(k) K261009
Substantially EquivalentWaldemar Link GmbH & Co. KG
FDA 510(k) clearance K261009 for MobileLink Acetabular Cup System 40mm ID Inserts (various), Substantially Equivalent on 2026-07-06. Applicant: Waldemar Link GmbH & Co. KG. Device class: 2.
Summary
Waldemar Link's clearance covers various 40mm ID inserts for the MobileLink Acetabular Cup System, filed under LZO, semi-constrained metal/ceramic/polymer hip prostheses (cemented or non-porous uncemented). The record doesn't list the individual inserts.
Class II, 21 CFR 888.3353. Orthopedic is both the classification panel and the review panel. It was a Traditional 510(k).
Waldemar Link filed from Hamburg, Germany. Review took 102 calendar days (March 26 to July 6, 2026).
Clearance details
- Applicant
- Waldemar Link GmbH & Co. KG
- Product code
- Product 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
- Hamburg, DE
Recent devices under product code LZO
view allMore clearances from Waldemar Link GmbH & Co. KG
view allAdverse 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.