JDL · Class III · 21 CFR 888.3320

FDA Product Code JDL: Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component)

Leading manufacturers include Wrightmedicaltechnologyinc, Howmedica Corp. and Osteonics Corp..

45
Total
45
Cleared
153d
Avg days
1977
Since

FDA 510(k) Cleared Prosthesis, Hip, Semi-constrained (metal Cemented Acetabular Component) Devices (Product Code JDL)

45 devices
1–24 of 45
Cleared Aug 07, 2008
VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIES
K073499
Zimmer, Inc.
Orthopedic · 238d
Cleared Jul 11, 2007
DYNASTY ACETABULAR SYSTEM
K070785
Wrightmedicaltechnologyinc
Orthopedic · 112d
Cleared Dec 06, 2006
DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINER
K061844
Wrightmedicaltechnologyinc
Orthopedic · 160d
Cleared Aug 22, 2005
PROFEMUR RENAISSANCE HIP STEM
K051995
Wrightmedicaltechnologyinc
Orthopedic · 28d
Cleared Aug 19, 2005
CONSERVE TOTAL FEMORAL HEAD
K051348
Wrightmedicaltechnologyinc
Orthopedic · 87d
Cleared Dec 21, 2004
M2A/C2A ACETABULAR SYSTEM
K042841
Biomet, Inc.
Orthopedic · 68d
Cleared Jul 09, 2004
PROFEMUR S HIP STEM
K041586
Wrightmedicaltechnologyinc
Orthopedic · 25d
Cleared May 28, 2004
PROFEMUR TAPERED HIP STEM
K041114
Wrightmedicaltechnologyinc
Orthopedic · 30d
Cleared Jul 13, 2001
METAL TRANSCEND ARTICULATION SYSTEM
K004043
Wrightmedicaltechnologyinc
Orthopedic · 196d
Cleared May 25, 1995
METAL BACKED ACETABULAR COMPONENT
K950542
Encore Orthopedics, Inc.
Orthopedic · 107d
Cleared Dec 08, 1994
P.F.C. APICAL PLUG
K944769
Johnson & Johnson Professionals, Inc.
Orthopedic · 72d
Cleared Sep 20, 1994
ACETABULAR DOME HOLE PLUGS
K942809
Osteonics Corp.
Orthopedic · 98d
Cleared May 18, 1994
S-ROM(R) ZTT(TM) ACETABULAR CUP-APICAL HOLE PLUG
K931676
Joint Medical Products Corp.
Orthopedic · 407d
Cleared Feb 22, 1994
PCA(R) SOLID BACK ACETABULA SHELL
K930833
Howmedica Corp.
Orthopedic · 370d
Cleared Feb 22, 1994
PCA ACETABULAR INSERT II, ADDITIONAL SIZES, STYLES
K934440
Howmedica Corp.
Orthopedic · 231d
Cleared May 05, 1993
POLY INSERT 20 DEGREE
K920929
Dow Corning Wright
Orthopedic · 432d
Cleared Feb 05, 1993
TECHMEDICA MUELLER TYPE POLYETHYLENE ACETBUL CUP
K925181
Techmedica, Inc.
Orthopedic · 114d
Cleared Jul 01, 1992
HEALEY REVISION COMPONENT SYSTEM
K921139
Biomet, Inc.
Orthopedic · 113d
Cleared Jun 25, 1992
PCA ACETABULAR INSERT II
K921384
Howmedica Corp.
Orthopedic · 94d
Cleared May 26, 1992
ACETABULAR DOME AND SCREW HOLE PLUGS
K920868
Osteonics Corp.
Orthopedic · 90d
Cleared Nov 17, 1989
POROUS-COATED TITANIUM ACETABULAR CUP
K894965
Dow Corning Wright
Orthopedic · 102d
Cleared Nov 17, 1989
POROUS COATED TOTAL HIP PROS. ACETABULAR COMPONENT
K895607
Exactech, Inc.
Orthopedic · 60d
Cleared Oct 11, 1989
PNEUMOTHORAX KIT, MOTIFICATION
K892640
Arrow Intl., Inc.
Orthopedic · 182d
Cleared May 08, 1987
KM-4(TM) METAL-BACKED ACETABULAR CUP
K870867
Kirschner Medical Corp.
Orthopedic · 66d

About Product Code JDL - Regulatory Context