ZIMMER(R) BONE CEMENT

FDA Premarket Approval N17755

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

DeviceZIMMER(R) BONE CEMENT
Generic NameBone Cement
ApplicantZIMMER, INC.
Date Received1976-05-17
Decision Date1976-05-17
PMAN17755
SupplementS
Product CodeLOD 
Advisory CommitteeOrthopedic
Expedited ReviewNo
Combination Product No
Applicant Address ZIMMER, INC. p.o. Box 708 warsaw, IN 46581-0708

Supplemental Filings

Supplement NumberDateSupplement Type
N17755Original Filing
S049 1997-05-01 Normal 180 Day Track
S048 1996-08-30 Normal 180 Day Track
S047 1996-06-21 Real-time Process
S046 1995-10-11 Special (immediate Track)
S045 1995-06-22 Normal 180 Day Track
S044 1994-08-01 Normal 180 Day Track
S043 1994-07-08 Special (immediate Track)
S042 1994-06-13 Normal 180 Day Track
S041 1992-09-18 Normal 180 Day Track
S040 1992-05-28 Special (immediate Track)
S039 1992-02-18 Normal 180 Day Track
S038
S037 1990-02-08 Normal 180 Day Track
S036 1990-01-12 Normal 180 Day Track
S035 1990-01-08 Special (immediate Track)
S034 1988-04-12 30-Day Supplement
S033 1986-09-03 Normal 180 Day Track
S032
S031 1984-08-24
S030
S029 1983-01-03
S028 1982-10-26
S027 1982-08-18
S026 1982-08-06
S025 1982-07-07
S024 1982-02-11
S023
S022 1981-06-29
S021 1981-05-22
S020
S019 1980-09-01
S018
S017
S016
S015
S014
S013
S012
S011
S010
S009
S008
S007
S006
S005
S004
S003
S002
S001

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