FOUNDATION POSTERIOR STABILIZED 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 Foundation Posterior Stabilized Knee.

Pre-market Notification Details

• Device ID: K933539
• 510k Number: K933539
• Device Name: FOUNDATION POSTERIOR STABILIZED KNEE
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin, TX 78759
• Contact: J.d. Webb
• Correspondent: J.d. Webb; ENCORE ORTHOPEDICS, INC. 8920 BUSINESS PARK DR. SUTIE 380 Austin, TX 78759
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1993-07-21
• Decision Date: 1994-11-08

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00888912114400	K933539	000
00888912116916	K933539	000
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