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FDA 510(k), K032418, DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
FDA 510(k), K032418, DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
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510(K) Number: K032418
Device Name: DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
Manufacturer: DENISE DUCHENE
Device Classification Name: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Regulation Number: MBH
Classification Product Code: KXA
Date Received: 08/05/2003
Decision Date: 09/11/2003
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
Device Name: DURACON TOTAL KNEE SYSTEM WITH PERI-APATITE COATING
Manufacturer: DENISE DUCHENE
Device Classification Name: Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Regulation Number: MBH
Classification Product Code: KXA
Date Received: 08/05/2003
Decision Date: 09/11/2003
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Orthopedic
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