FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL 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 Total Knee Cruciate Retaining (cr) Femoral Component.

Pre-market Notification Details

• Device ID: K091280
• 510k Number: K091280
• Device Name: FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL 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: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-05-01
• Decision Date: 2009-09-25
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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