510(k) Premarket Notification

• Device Classification Name: Shoulder Prosthesis, Reverse Configuration
• 510(k) Number: K060704
• Device Name: ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, SIZES 8MM AND 10MM
• Applicant: ZIMMER, INC.; P.O. BOX 708; WARSAW, IN 46581 -0708
• Applicant Contact: DALENE T BINKLEY
• Correspondent: ZIMMER, INC.; P.O. BOX 708; WARSAW, IN 46581 -0708
• Correspondent Contact: DALENE T BINKLEY
• Regulation Number: 888.3660
• Classification Product Code: PHX
• Subsequent Product Codes: HSD KWS KWT
• Date Received: 03/16/2006
• Decision Date: 05/19/2006
• Decision: Substantially Equivalent (SESE)
• Regulation Medical Specialty: Orthopedic
• 510k Review Panel: Orthopedic
• Summary: Summary
• Type: Special
• Reviewed by Third Party: No
• Combination Product: No
• Recalls: CDRH Recalls