MOTIVATION KNEE SYSTEM

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

ENCORE MEDICAL, L.P.

The following data is part of a premarket notification filed by Encore Medical, L.p. with the FDA for Motivation Knee System.

Pre-market Notification Details

• Device ID: K100900
• 510k Number: K100900
• Device Name: MOTIVATION KNEE SYSTEM
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: ENCORE MEDICAL, L.P. 9800 METRIC BLVD. Austin, TX 78758
• Contact: Elizabeth Onderlinde
• Correspondent: Elizabeth Onderlinde; ENCORE MEDICAL, L.P. 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: 2010-03-31
• Decision Date: 2010-06-18
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00888912108454	K100900	000
00888912112130	K100900	000
00888912112147	K100900	000
00888912112161	K100900	000
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