Gotfried Percutaneous Compression Plating System

FDA 510(k) K983814 · Efratgo, Ltd. HI Tech Bio-Surgical

Substantially Equivalent

510(k) numberK983814

Submission

Device name
Gotfried Percutaneous Compression Plating System
Applicant
Efratgo, Ltd. HI Tech Bio-Surgical
Washington, DC, US
Received
October 28, 1998
Decision date
January 14, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JDO – Device, Fixation, Proximal Femoral, Implant
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3030
Specialty
Orthopedic
Implant
Yes

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K080685Hiploc Compression Hip ScrewJDO · Traditional Biomet Manufacturing, Inc.08/15/2008SE
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More from Smith & Nephew, Inc.

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K083648Gotfried Physiological Hip (PH) NailHSB · Traditional 05/14/2009SE
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Questions and answers

When was Gotfried Percutaneous Compression Plating System cleared by the FDA?

Gotfried Percutaneous Compression Plating System (K983814) received a 510(k) decision of Substantially Equivalent on January 14, 1999, 78 days after the submission was received.

What is the product code of K983814?

The FDA product code is JDO – Device, Fixation, Proximal Femoral, Implant, a Class II (moderate risk) device regulated under 21 CFR 888.3030.