510(k) Premarket Notification

• Device Classification Name: Plate, Fixation, Bone
• 510(k) Number: K042695
• Device Name: NCB PLATING SYSTEM
• Applicant: ZIMMER GMBH; P.O. BOX 708; WARSAW, IN 46581 -0708
• Applicant Contact: STEPHEN H MCKELVEY
• Correspondent: ZIMMER GMBH; P.O. BOX 708; WARSAW, IN 46581 -0708
• Correspondent Contact: STEPHEN H MCKELVEY
• Regulation Number: 888.3030
• Classification Product Code: HRS
• Subsequent Product Code: HWC
• Date Received: 09/30/2004
• Decision Date: 10/29/2004
• Decision: Substantially Equivalent (SESE)
• Regulation Medical Specialty: Orthopedic
• 510k Review Panel: Orthopedic
• Summary: Summary
• Type: Traditional
• Reviewed by Third Party: No
• Combination Product: No
• Recalls: CDRH Recalls