Patriot Protrusio Cage

FDA 510(k) K020076 · Biomet Orthopedics, Inc.

Substantially Equivalent

510(k) numberK020076

Submission

Device name
Patriot Protrusio Cage
Applicant
Biomet Orthopedics, Inc.
Warsaw, IN, US
Received
January 9, 2002
Decision date
January 30, 2002
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
Device class
Class II (moderate risk)
Regulation
21 CFR 888.3350
Specialty
Orthopedic
Implant
Yes

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Questions and answers

When was Patriot Protrusio Cage cleared by the FDA?

Patriot Protrusio Cage (K020076) received a 510(k) decision of Substantially Equivalent on January 30, 2002, 21 days after the submission was received.

What is the product code of K020076?

The FDA product code is JDI – Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented, a Class II (moderate risk) device regulated under 21 CFR 888.3350.