Skip to content
MedTekOSTry the sandbox

FDA 510(k) clearance · back to tracker

MobileLink Acetabular Cup System – 40mm ID Inserts (various)

Waldemar Link GmbH & Co. KG cleared K261009 on 2026-07-06, decision: substantially equivalent

K-number

K261009

Sponsor

Waldemar Link GmbH & Co. KG

Device

MobileLink Acetabular Cup System – 40mm ID Inserts (various)

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-07-06

Product code

LZO

Advisory committee

Orthopedic

Medical specialty

Orthopedic

Regulation number

888.3353

Official FDA record

Open K261009on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K261009 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.