3D KNEE

Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer

ENCORE ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Encore Orthopedics, Inc. with the FDA for 3d Knee.

Pre-market Notification Details

• Device ID: K020114
• 510k Number: K020114
• Device Name: 3D KNEE
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758
• Contact: Joanna Droege
• Correspondent: Joanna Droege; ENCORE ORTHOPEDICS, INC. 9800 METRIC BLVD. Austin, TX 78758
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-01-11
• Decision Date: 2002-07-12
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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