510(k) Premarket Notification

• Device Classification Name: fastener, fixation, nondegradable, soft tissue
• 510(K) Number: K122314
• Models: CM-9129, CM-9145, CM-9145SP, CM-9155
• Device Name: QUATRO LINK KNOTLESS ANCHOR WITH INSERTER, 2.9MM-PEEK ONLY
• Applicant: CAYENNE MEDICAL, INC.; 16597 n. 92nd street; suite 101; scottsdale, AZ 85260
• Contact: kereshmeh shahriari
• Regulation Number: 888.3040
• Classification Product Code: MBI
• Date Received: 08/01/2012
• Decision Date: 10/31/2012
• 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