FREEDOM(R) STEMMED TIBIAL COMPONENTS

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

MAXX ORTHOPEDICS, INC.

The following data is part of a premarket notification filed by Maxx Orthopedics, Inc. with the FDA for Freedom(r) Stemmed Tibial Components.

Pre-market Notification Details

• Device ID: K111785
• 510k Number: K111785
• Device Name: FREEDOM(R) STEMMED TIBIAL COMPONENTS
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: MAXX ORTHOPEDICS, INC. 2260 BUTLER PIKE, SUITE 100 Plymouth Meeting, PA 19462
• Contact: Nache Dave
• Correspondent: Nache Dave; MAXX ORTHOPEDICS, INC. 2260 BUTLER PIKE, SUITE 100 Plymouth Meeting, PA 19462
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-06-24
• Decision Date: 2012-06-29

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00811767024242	K111785	000
00811767024419	K111785	000
00811767024426	K111785	000
00811767024433	K111785	000
00811767024440	K111785	000
00811767024457	K111785	000
00811767024464	K111785	000
00811767024471	K111785	000
00811767024488	K111785	000
00811767024495	K111785	000
00811767024501	K111785	000
00811767024518	K111785	000
00811767024525	K111785	000
00811767024532	K111785	000
00811767024549	K111785	000
00811767024402	K111785	000
00811767024396	K111785	000
00811767024259	K111785	000
00811767024266	K111785	000
00811767024273	K111785	000
00811767024280	K111785	000
00811767024297	K111785	000
00811767024303	K111785	000
00811767024310	K111785	000
00811767024327	K111785	000
00811767024334	K111785	000
00811767024341	K111785	000
00811767024358	K111785	000
00811767024365	K111785	000
00811767024372	K111785	000
00811767024389	K111785	000
00811767024556	K111785	000
00811767024563	K111785	000
00811767024761	K111785	000
00811767024785	K111785	000
00811767024792	K111785	000
00811767024808	K111785	000
00811767024815	K111785	000
00811767024822	K111785	000
00811767024839	K111785	000
00811767024846	K111785	000
00811767024907	K111785	000
00811767025478	K111785	000
00811767025485	K111785	000
00811767025492	K111785	000
00811767025508	K111785	000
00811767025515	K111785	000
00811767024754	K111785	000
00811767024730	K111785	000
00811767024570	K111785	000
00811767024587	K111785	000
00811767024594	K111785	000
00811767024600	K111785	000
00811767024617	K111785	000
00811767024624	K111785	000
00811767024631	K111785	000
00811767024648	K111785	000
00811767024655	K111785	000
00811767024679	K111785	000
00811767024686	K111785	000
00811767024709	K111785	000
00811767024716	K111785	000
00811767024723	K111785	000
00811767025522	K111785	000