FOUNDATION KNEE AUGMENTATION BLOCKS

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 Knee Augmentation Blocks.

Pre-market Notification Details

• Device ID: K941306
• 510k Number: K941306
• Device Name: FOUNDATION KNEE AUGMENTATION BLOCKS
• 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 For Some Indications (SN)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1994-03-17
• Decision Date: 1995-02-08

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00888912109734	K941306	000
00888912109055	K941306	000
00888912109062	K941306	000
00888912109079	K941306	000
00888912109086	K941306	000
00888912109109	K941306	000
00888912109116	K941306	000
00888912109123	K941306	000
00888912109727	K941306	000
00888912109741	K941306	000
00888912109819	K941306	000
00888912109826	K941306	000
00888912109833	K941306	000
00888912109840	K941306	000
00888912109857	K941306	000
00888912109048	K941306	000
00888912109031	K941306	000
00888912109765	K941306	000
00888912109772	K941306	000
00888912109789	K941306	000
00888912109796	K941306	000
00888912109802	K941306	000
00888912114707	K941306	000
00888912114950	K941306	000
00888912114974	K941306	000
00888912114646	K941306	000
00888912114721	K941306	000
00888912114882	K941306	000
00888912108997	K941306	000
00888912109000	K941306	000
00888912109017	K941306	000
00888912109864	K941306	000
00888912109871	K941306	000
00888912114752	K941306	000
00888912114776	K941306	000
00888912114783	K941306	000
00888912114790	K941306	000
00888912114899	K941306	000
00888912114905	K941306	000
00888912114929	K941306	000
00888912114943	K941306	000
00888912114967	K941306	000
00888912114981	K941306	000
00888912114998	K941306	000
00888912115001	K941306	000
00888912115025	K941306	000
00888912115032	K941306	000
00888912114745	K941306	000
00888912114738	K941306	000
00888912109895	K941306	000
00888912109901	K941306	000
00888912109918	K941306	000
00888912109925	K941306	000
00888912109932	K941306	000
00888912109949	K941306	000
00888912109963	K941306	000
00888912109970	K941306	000
00888912109987	K941306	000
00888912114653	K941306	000
00888912114660	K941306	000
00888912114677	K941306	000
00888912114691	K941306	000
00888912114714	K941306	000
00888912115049	K941306	000