510(k) Premarket Notification

• Device Classification Name: fastener, fixation, nondegradable, soft tissue
• 510(K) Number: K112876
• Model: CM-9145, CM-9155, CM-9145SP
• Device Name: CUFFLINK(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5MM/5.5MM - PEEK ONLY, CUFFLINK SP(TM) KNOTLESS ANCHOR WITH INSERTER, 4.5
• Applicant: CAYENNE MEDICAL, INC.; 16597 n. 92nd street; suite 101; scottsdale, AZ 85260
• Contact: kereshmeh shahriari
• Regulation Number: 888.3040
• Classification Product Code: MBI
• Subsequent Product Code: HWC
• Date Received: 09/30/2011
• Decision Date: 12/15/2011
• Decision: substantially equivalent (SE)
• Classification Advisory Committee: Orthopedic
• Review Advisory Committee: Orthopedic
• summary: summary
• Type: Traditional
• Reviewed by Third Party: No
• Expedited Review: No
• Combination Product: No