Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.
Description du dispositif
Natural-Knee¿ || N-K II DOMED ALL-POLY PAT, SZ0 || N-K II DOMED ALL-POLY PAT, SZ1
“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) and Internationally to ARGENTINA AUSTRALIA AUSTRIA BARBADOS BELGIUM BERMUDA BOLIVIA BRAZIL CARIBBEAN CHILE CHINA COLOMBIA COST RICA DENMARK DOMINICAN REPUBLIC DORAL FL ECUADOR EL SALVADOR ENGLAND FRANCE GERMANY GUATEMALA HONDURAS HONG KONG INDIA ISRAEL ITALY JAMAICA JAPAN KOREA MALAYSIA MEXICO NEW ZEALAND NICARAGUA PANAMA PERU SINGAPORE SPAIN SWEDEN SWITZERLAND TAIWAN THAILAND VENEZUELA WEST INDIES Canary Islands Croatia Cyprus Czech Republic Canada
Description du dispositif
NKII CSTI Porous Femoral || NKII NP Femoral || prosthesis, knee, patellofemorotibial, semi-constrained, cemented, polymer/metal/polymer || variou sizes || Product Usage "" The Natural-Knee II System with Cancellous-Structured Titanium (CSTi) Porous Coating is indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD). " The Natural-Knee II primary components without CSTi Porous Coating, all posterior stabilized and revision components, the N-K II Constrained Knee System, the modular cemented tibial baseplate, and the revision stem and revision fluted stem are indicated for cemented use only in skeletally mature individuals with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable valgus-varus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists. When the primary or N-K II Constrained Knee System components are used, the medial and collateral ligaments must be intact. " The Natural-Knee II Durasul polyethylene components are indicated for patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g., avascular necrosis, osteoarthritis, and inflammatory degenerative joint disease (IJD), e.g., rheumatoid arthritis; correctable valgus-varus deformity and moderate flexion contracture; those patients with failed previous surgery where pain, deformity, or dysfunction persists; and revision of previously failed knee arthroplasty. These devices are intended for cemented use only in the United States."
Worldwide Distribution: US (nationwide) and countries of: Argentina, Australia, Brazil, Bolivia, Canada, Chile, China, Colombia, Ecuador, El Salvador, India, Japan, Malaysia, Mexico, Netherlands, New Zealand, Nicaragua, Panama, Seoul-Korea, Singapore, Taiwan, Thailand, and UAE.
Description du dispositif
NP FEM LT SZ0 NATURAL-KNE || NP FEM RT SZ0 NATURAL-KNE || NP FEM LT SZ2 NATURAL-KNE || NP FEM RT SZ2 NATURAL-KNE || NP FEM LT SZ3 NATURAL-KNE || The Natural-Knee II System with Cancellous-Structured Titanium (CSTi) Porous Coating
Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.
Description du dispositif
Natural-Knee¿ II System || ULTRA CONG INS LT SZA/9MM || ULTRA CONG INS LT SZA/13M || ULTRA CONG INS LT SZA/19M || ULTRA CONG INS RT SZA/9MM || ULTRA CONG INS RT SZA/11M || ULTRA CONG INS RT SZA/13M || ULTRA CONG INS RT SZA/19M || ULTRA CONG INS LT SZB/13M || ULTRA CONG INS LT SZB/16M || ULTRA CONG INS RT SZB/19M || ULTRA CONG INS RT SZB/22M || NKII ROT PLTFM U/C INS, 9 || NKII ROT PLTFM U/C INS, 1 || NKII ROT PLTFM U/C INS, 1 || NKII ROT PLTFM U/C INS, 1 || NKII ROT PLTFM U/C INS, 1 || NKII ROT PLTFM U/C INS, 1 || NKII ROT PLTFM U/C INS, 1 || NKII ROT PLTFM U/C INS, 1 || NKII ROT PLTFM U/C INS, 1 || NKII ROT PLTFM U/C INS, 1 || NKII ROT PLTFM U/C INS, 1 || NKII ROT PLTFM U/C INS, 1 || NKII ROT PLTFM U/C INS, 1 || NKII ROT PLTFM U/C INS, 1 || ALL POLY CONG TIB LT SZ00 || ALL POLY CONG TIB LT SZ0/ || ALL POLY CONG TIB LT SZ0/ || ALL POLY CONG TIB RT SZ0/ || ALL POLY CONG TIB RT SZ0/ || ALL POLY CONG TIB LT SZ1/ || ALL POLY CONG TIB LT SZ1/ || ALL POLY CONG TIB RT SZ1/ || ALL POLY CONG TIB RT SZ1/ || ALL POLY CONG TIB RT SZ1/ || ALL POLY CONG TIB LT SZ2/ || ALL POLY CONG TIB LT SZ2/ || ALL POLY CONG TIB LT SZ2/ || ALL POLY CONG TIB LT SZ2/ || ALL POLY CONG TIB RT SZ2/ || ALL POLY CONG TIB RT SZ2/ || ALL POLY CONG TIB RT SZ2/ || ALL POLY CONG TIB LT SZ3/ || ALL POLY CONG TIB LT SZ3/ || ALL POLY CONG TIB LT SZ3/ || ALL POLY CONG TIB RT SZ3/ || ALL POLY CONG TIB RT SZ3/ || ALL POLY CONG TIB RT SZ3/ || ALL POLY CONG TIB LT SZ4/ || ALL POLY CONG TIB LT SZ4/ || ALL POLY CONG TIB RT SZ4/ || ALL POLY CONG TIB RT SZ4/ || ALL POLY CONG TIB RT SZ5/ || PS TIB INS RT SZ1/2 16MM || PS TIB INS RT SZ1/2 19MM || PS TIB INS LT SZ00/0 19MM || PS TIB INS RT SZ00/0 11MM || PS TIB INS RT SZ00/0 16MM
Worldwide Distribution-USA (nationwide) including DC and the states of AK, AL, AR, AZ, CA, CO, CT, FL, IL, IN, KS, LA, ME, MI, MO, MS, NC, ND, NE, NJ, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA, and WI, and the countries of Canada, Australia, India, Austria, Japan, Czech Republic, Seoul Korea, France, Venezuela, Germany, Luxembourg, Spain, and Switzerland.
Description du dispositif
Natural-Knee¿ II System: || POLY ULTRA TIB LT SZ00/9M || POLY ULTRA TIB LT SZ0/9MM || POLY ULTRA TIB LT SZ0/19M || POLY ULTRA TIB RT SZ0/13M || POLY ULTRA TIB RT SZ0/16M || ALL POLY ULTRA TIB LT SZ1 || ALL POLY ULTRA TIB RT SZ1 || ALL POLY ULTRA TIB LT SZ2 || ALL POLY ULTRA TIB LT SZ2 || ALL POLY ULTRA TIB RT SZ2 || ALL POLY ULTRA TIB LT SZ3 || ALL POLY ULTRA TIB RT SZ3 || ALL POLY ULTRA TIB RT SZ5