MSA HIP SYSTEM— 510(k) K113107

Name: FDA 510(k) clearance K113107
Creator: U.S. Food and Drug Administration
Published: 2011-12-15

Substantially Equivalent

Global Manufacturing Technology

FDA 510(k) clearance K113107 for MSA HIP SYSTEM, Substantially Equivalent on 2011-12-15. Applicant: Global Manufacturing Technology. Device class: 2.

Clearance details

Applicant: Global Manufacturing Technology
Product code: Code MEH
Device class: Class 2
Regulation: 21 CFR 888.3353
Advisory panel: Orthopedic
Date received: 2011-10-20
Decision date: 2011-12-15
Decision: Substantially Equivalent
Clearance type: Special
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MEH

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K261576 — Icona Hip Stem2026-08-10
K250375 — Allure Hip Stem and Intramedullary Plugs2025-11-05
K251166 — Mfinity Femoral System2025-06-13
K251052 — Trivicta® Hip Stem2025-05-22
K242315 — Resolve Modular Revision Hip Stem2025-05-01

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K123782 — PARAGON HIP SYSTEM2013-03-14
K102172 — MSA HIP SYSTEM2011-03-01

Adverse events under product code MEH

product code MEH

Injury: 2,021
Total: 2,021

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.