Encore CLP Offset Total Hip System

FDA 510(k) K052320 · Encore Medical Corporation

Substantially Equivalent

510(k) numberK052320

Submission

Device name
Encore CLP Offset Total Hip System
Applicant
Encore Medical Corporation
Hunt Valley, MD, US
Received
August 25, 2005
Decision date
December 30, 2005
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
KWA – Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Device class
Class III (high risk)
Regulation
21 CFR 888.3330
Specialty
Orthopedic
Implant
Yes

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K110400Taperloc Complete Microplasty StemKWA · Traditional Biomet Manufacturing Corp09/30/2011SE

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Questions and answers

When was Encore CLP Offset Total Hip System cleared by the FDA?

Encore CLP Offset Total Hip System (K052320) received a 510(k) decision of Substantially Equivalent on December 30, 2005, 127 days after the submission was received.

What is the product code of K052320?

The FDA product code is KWA – Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component), a Class III (high risk) device regulated under 21 CFR 888.3330.