PMA P940002S003

Device
NATURAL KNEE & NATURAL KNEE II
Applicant
Sulzermedica
PMA number
P940002
Supplement
S003
Product code
MBD
Decision date
2000-04-18
Classification
Prosthesis, Knee, Patello/femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/metal/polymer
Generic name
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
Approval order statement
Approval for use of forged Ti alloy as a material for the construction of the stemmed tibial base plate component of the devices.

Current openFDA PMA Record#

Device
NATURAL KNEE & NATURAL KNEE II
Applicant
Sulzermedica
PMA number
P940002
Supplement
S003
Product code
MBD
Generic name
PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER
Decision date
2000-04-18
Decision code
APPR
Date received
2000-03-24
Supplement type
Special (Immediate Track)
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Approval for use of forged Ti alloy as a material for the construction of the stemmed tibial base plate component of the devices.