Worldwide Distribution - US including OH AZ ID PA AR MN IL CA MD CA MN NY Foreign: Canada
Description du dispositif
Modular Hybrid Glenoid Base Large for the Comprehensive Shoulder System, The product is placed into an AlOx coated PET pouch and vacuum sealed with an Argon flush. The vacuum sealed product is then placed into a Tyvek/film pouch and that pouch is heat sealed. The fully pouched product is then labeled and placed into a carton with an IFU. The carton is then labeled and shrink wrapped. The labels also include a sterilization indication dot. || This system is intended for primary and revision total shoulder arthroplasty, as well as hemi-arthroplasty
“The safety of patients has always been, and continues to be, Zimmer Biomet’s top priority and it is our honor to be a leader in this industry for the past 90 years,” Zimmer Biomet told ICIJ in a statement. “We adhere to strict regulatory standards, and work closely with the FDA and all applicable regulatory agencies in each of our regions as part of our commitment to operating a first-rate quality management system across our global manufacturing network. The company added that it is focused on staying at the forefront of innovation and doing right by the millions of patients who rely on the company’s products.
Worldwide Distribution - US Nationwide in the states of AR, CA, IL, IN, PA, FL, KS, LA, WI, VA, MA, MD, NJ, UT, NC, TX, AL, MI, KY, OH, SD, MO, GA, NV, WA and the countries of: Europe, Canada, Japan, Chile, Korea, Mexico, New Zealand, Trinidad/Tobago, Thailand, Argentina, Australia, and China.
Description du dispositif
Comprehensive Shoulder System, 4 mm, 122 mm long, Primary Shoulder Stem, Ti-6Al-4V, Standard Length Porous Plasma. Shoulder joint replacement components include humeral stems, humeral heads, and glenoid components.
Model Catalog: 115732 (Lot serial: ALL LOTS); Model Catalog: 115734 (Lot serial: ALL LOTS); Model Catalog: 115736 (Lot serial: ALL LOTS); Model Catalog: 115738 (Lot serial: ALL LOTS); Model Catalog: 115740 (Lot serial: ALL LOTS); Model Catalog: 115730 (Lot serial: ALL LOTS)
Description du dispositif
COMPREHENSIVE SHOULDER SYSTEM NANO HUMERAL COMPONENT