Premarket Approval (PMA)

Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.

• Trade Name: TOTAL TEMPOROMANDIBULAR JOINT REPLACEMENT SYSTEM
• Classification Name: joint, temporomandibular, implant
• Regulation Number: 872.3940
• Applicant: WALTER LORENZ SURGICAL, INC.
• PMA Number: P020016
• Supplement Number: S003
• Date Received: 09/24/2009
• Decision Date: 10/21/2009
• Product Code: LZD [ Registered Establishments with LZD ]
• Advisory Committee: Dental
• Supplement Type: real-time process
• Supplement Reason: labeling change - instructions
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for a stand-alone surgical technique manual.