GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM— 510(k) K983814

Name: FDA 510(k) clearance K983814
Creator: U.S. Food and Drug Administration
Published: 1999-01-14

Substantially Equivalent

Efratgo, Ltd. HI Tech Bio-Surgical

FDA 510(k) clearance K983814 for GOTFRIED PERCUTANEOUS COMPRESSION PLATING SYSTEM, Substantially Equivalent on 1999-01-14. Applicant: Efratgo, Ltd. HI Tech Bio-Surgical. Device class: 2.

Clearance details

Applicant: Efratgo, Ltd. HI Tech Bio-Surgical
Product code: Code JDO
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 1998-10-28
Decision date: 1999-01-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.