510(k) Premarket Notification

• Device Classification Name: prosthesis, shoulder, non-constrained, metal/polymer cemented
• 510(K) Number: K121067
• Device Name: EXACTECH EQUINOXE SHOULDER SYSTEM TORQUE DEFINING SCREW AND SHORT REPLICATOR PLATE
• Applicant: EXACTECH, INC.; 2320 n.w. 66th ct.; gainesville, FL 32653
• Contact: lindy knisely
• Regulation Number: 888.3650
• Classification Product Code: KWT
• Subsequent Product Codes: HSD KWS
• Date Received: 04/11/2012
• Decision Date: 12/06/2012
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Orthopedic
• Review Advisory Committee: Orthopedic
• summary: summary
• Type: Special
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No