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Ceramtec Ag

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Contact: Goetz Griesmayr
Web: http://www.ceramtec.com
E-Mail:
Address: Fabrikstr. 23-29, Plochingen 73207, Germany
Phone: +49-(7153)-611-0 | Fax: +49-(7153)-25421 | Map/Directions >>
 
 

Profile: Ceramtec Ag develops, manufactures, and sales a range of ceramic products to the medical industries. Our medical ceramic products include knee joining components, surgical knives, hip joining components, protective wears, dental ceramics, ball heads, cup inserts and chip resistors. We supply feedthrough connectors, LTCC ceramic tapes, resistor cores, revision balls, tapes, tubes, vacuum seal products, substrates, lab porcelain, glove dipping formers and allied products.

The company is ISO 13485:2003 certified.

FDA Registration Number: 8044172
US Agent: Rebecca Echols / Ceramtec Gmbh Medical Products Division
Phone: +1-(505)-328-2477  E-Mail:

4 Products/Services (Click for related suppliers)  
• Cemented Metal/Polymer Semi-Constrained Hip Prosthesis (FDA Code: JDI / 888.3350)
A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (888.3027).
• Cemented/Uncemented Semi-constrained Hip Prosthesis (FDA Code: MRA)
• Uncemented Metal/Polymer Semi-Constrained Hip Prosthesis (FDA Code: LWJ / 888.3360)
A hip joint femoral (hemi-hip) metallic cemented or uncemented prosthesis is a device intended to be implanted to replace a portion of the hip joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum. This generic type of device includes designs which are intended to be fixed to the bone with bone cement (888.3027) as well as designs which have large window-like holes in the stem of the device and which are intended for use without bone cement. However, in these latter designs, fixation of the device is not achieved by means of bone ingrowth.
• Uncemented, Cemented Or Non-Porous Metal/Ceramic/Polymer Semi-Constrained Hip Prosthesis (FDA Code: LZO / 888.3353)
A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A1203) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.

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