TILLMAN HIPSURFACE REPLACEMENT— 510(k) K781490

Name: FDA 510(k) clearance K781490
Creator: U.S. Food and Drug Administration
Published: 1978-09-20

Substantially Equivalent

Waldemar Link GmbH & Co. KG

FDA 510(k) clearance K781490 for TILLMAN HIPSURFACE REPLACEMENT, Substantially Equivalent on 1978-09-20. Applicant: Waldemar Link GmbH & Co. KG. Device class: 2.

Clearance details

Applicant: Waldemar Link GmbH & Co. KG
Product code: Code KXA
Device class: Class 2
Regulation: 21 CFR 888.3400
Advisory panel: Orthopedic
Date received: 1978-08-28
Decision date: 1978-09-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

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K071053 — RECAP HA PRESS-FIT FEMORAL RESURFACING HEAD2007-06-29
K070292 — DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS2007-04-26

Adverse events under product code KXA

product code KXA

Injury: 324
Total: 324

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.

Clearance details

Recent devices under product code KXA

More clearances from Waldemar Link GmbH & Co. KG

Adverse events under product code KXA