EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP— 510(k) K994146

Name: FDA 510(k) clearance K994146
Creator: U.S. Food and Drug Administration
Published: 2000-12-11

Substantially Equivalent

Plus Orthopedics

FDA 510(k) clearance K994146 for EPF-PLUS CEMENTLESS PRESS-FIT ACETABULAR CUP, Substantially Equivalent on 2000-12-11. Applicant: Plus Orthopedics. Device class: 2.

Clearance details

Applicant: Plus Orthopedics
Product code: Code LWJ
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1999-12-08
Decision date: 2000-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasant Hill, CA, US

Download summary PDF View on FDA.gov ↗

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K082146 — METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD2008-09-09
K070061 — 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT2007-01-31

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K032548 — IP-XS COMPRESSION NAIL SYSTEM2003-09-10
K032215 — VKS/TC-PLUS REVISION KNEE2003-08-08

Adverse events under product code LWJ

product code LWJ

Injury: 544
Total: 544

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.