INTERMOORE FRACTURE HIP STEM (MODIFY)— 510(k) K963155

Name: FDA 510(k) clearance K963155
Creator: U.S. Food and Drug Administration
Published: 1996-10-01

Substantially Equivalent

Intermedics Orthopedics

FDA 510(k) clearance K963155 for INTERMOORE FRACTURE HIP STEM (MODIFY), Substantially Equivalent on 1996-10-01. Applicant: Intermedics Orthopedics. Device class: 2.

Clearance details

Applicant: Intermedics Orthopedics
Product code: Code LWJ
Device class: Class 2
Regulation: 21 CFR 888.3360
Advisory panel: Orthopedic
Date received: 1996-08-05
Decision date: 1996-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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K070061 — 36MM COCR FEMORAL HEAD AND 36MM ACETABULAR INSERT2007-01-31

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K970567 — SELECT SHOULDER CURVED-BACK PEGGED ALL POLY GLENOIDS1997-02-27
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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.