LOD · Class II · 21 CFR 888.3027

FDA Product Code LOD: Bone Cement

Leading manufacturers include DePuy Orthopaedics, Inc., Heraeus Medical GmbH and Biomet, Inc..

72
Total
72
Cleared
167d
Avg days
2000
Since
72 devices
25–48 of 72
Cleared Apr 22, 2016
OSTEOPAL plus
K153737
Heraeus Medical GmbH
Orthopedic · 116d
Cleared Dec 14, 2015
V-STEADY, V-FAST
K150408
G21, S.R.L.
Orthopedic · 299d
Cleared Jun 17, 2015
PALACOS R pro
K150119
Heraeus Medical GmbH
Orthopedic · 148d
Cleared Mar 05, 2015
NP Cement HV Genta
K143100
Cossington, Ltd.
Orthopedic · 128d
Cleared Mar 05, 2015
NP Cement HV
K143134
Cossington, Ltd.
Orthopedic · 125d
Cleared Sep 05, 2014
PALACOS R+G PRO
K142157
Heraeus Medical GmbH
Orthopedic · 30d
Cleared Mar 15, 2013
BONOS R 1X20, BONOS R 2X20, BONOS R 1X40, BONOS R 2X40, BONOS R 1X60
K123225
Aap Biomaterials GmbH & Co. KG
Orthopedic · 151d
Cleared Mar 07, 2013
BONOS R GENTA 1X20 MODEL 01-0228
K123081
Aap Biomaterials GmbH & Co. KG
Orthopedic · 157d
Cleared Oct 27, 2009
COBALT MV WITH GENTAMICIN (AKA COBALT G-MV) BONE CEMENT
K092150
Biomet, Inc.
Orthopedic · 103d
Cleared Sep 17, 2009
COBALT MV BONE CEMENT
K091608
Biomet Manufacturing Corp
Orthopedic · 106d
Cleared May 14, 2008
SMARTSET MV BONE CEMENT
K081155
DePuy Orthopaedics, Inc.
Orthopedic · 21d
Cleared Nov 30, 2007
COBALT V RADIOPAQUE VERTEBROPLASTY BONE CEMENT
K070015
Biomet Manufacturing Corp
Orthopedic · 331d
Cleared Jan 08, 2007
SIMPLEX P BONE CEMENT
K062553
Stryker Orthopaedics
Orthopedic · 131d
Cleared Jan 26, 2006
SIMPLEX P SPEEDSET BONE CEMENT
K053198
Howmedica Osteonics Corp.
Orthopedic · 71d
Cleared Jan 06, 2006
SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT
K053445
DePuy Orthopaedics, Inc.
Orthopedic · 25d
Cleared Nov 22, 2005
DEPUY CMW 1, 2 AND 3 BONE CEMENTS
K053003
DePuy Orthopaedics, Inc.
Orthopedic · 27d
Cleared Sep 14, 2005
OSTEOPAL V
K050085
Heraeus Kulzer,GmbH
Orthopedic · 244d
Cleared Aug 04, 2005
COBALT BONE CEMENT
K051496
Biomet, Inc.
Orthopedic · 59d
Cleared Aug 03, 2005
COBALT G HV BONE CEMENT
K051532
Biomet, Inc.
Orthopedic · 55d
Cleared Jul 07, 2005
PALACOS LV+G
K050854
Heraeus Kulzer,GmbH
Orthopedic · 94d
Cleared Jul 07, 2005
PALAMED G
K050855
Heraeus Kulzer,GmbH
Orthopedic · 94d
Cleared Dec 28, 2004
CEMEX SYSTEM GENTA FAST BONE CEMENT
K043403
Exactech, Inc.
Orthopedic · 18d
Cleared Jul 01, 2004
MODIFICATION TO DEPUY 1 GENTAMICIN BONE CEMENT AND SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT
K041656
DePuy Orthopaedics, Inc.
Orthopedic · 13d
Cleared May 25, 2004
SIMPLEX X
K032945
Stryker Corp.
Orthopedic · 246d