FREEDOM METAL BACKED TIBIAL COMPONENT

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 Metal Backed Tibial Component.

Pre-market Notification Details

• Device ID: K090411
• 510k Number: K090411
• Device Name: FREEDOM METAL BACKED TIBIAL COMPONENT
• Classification: Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer
• Applicant: MAXX ORTHOPEDICS, INC. 49 PLAIN ST. North Attleboro, MA 02760
• Contact: Mary Mcnamara-cullinane
• Correspondent: Mary Mcnamara-cullinane; MAXX ORTHOPEDICS, INC. 49 PLAIN ST. North Attleboro, MA 02760
• Product Code: JWH
• CFR Regulation Number: 888.3560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-02-18
• Decision Date: 2009-04-07
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00811767021289	K090411	000
00811767021456	K090411	000
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00811767022484	K090411	000