510(k) Premarket Notification

• Device Classification Name: prosthesis, toe, hemi-, phalangeal
• 510(K) Number: K121973
• Model: 19538,19539,19540,19541,19542,19815,19816,19817,19818,19819
• Device Name: BIOPRO HEMI-EDGE TOE SYSTEM
• Applicant: BIOPRO, INC.; 3150 e. 200th st; prior lake, MN 55372
• Contact: al lippincott
• Regulation Number: 888.3730
• Classification Product Code: KWD
• Date Received: 07/05/2012
• Decision Date: 10/30/2012
• 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