LOD · Class II · 21 CFR 888.3027

FDA Product Code LOD: Bone Cement

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

72
Total
72
Cleared
167d
Avg days
2000
Since
72 devices
25–48 of 72
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 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 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 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
Cleared May 10, 2004
CEMEX GENTA BONE CEMENT
K033596
Exactech, Inc.
Orthopedic · 178d
Cleared Apr 29, 2004
VERSABOND AB BONE CEMENT
K022688
Smith & Nephew, Inc.
Orthopedic · 625d
Cleared Feb 05, 2004
SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT
K033382
DePuy Orthopaedics, Inc.
Orthopedic · 105d
Cleared Feb 05, 2004
SMARTSET GHV GENTAMICIN BONE CEMENT
K033563
DePuy Orthopaedics, Inc.
Orthopedic · 85d
Cleared Dec 17, 2003
PALACOS R BONE CEMENT WITH GENTAMICIN
K030086
Biomet, Inc.
Orthopedic · 342d
Cleared Nov 28, 2003
MODIFICATION TO VERSABOND BONE CEMENT
K033509
Smith & Nephew, Inc.
Orthopedic · 22d
Cleared Sep 29, 2003
DEPUY 1 GENTAMICIN BONE CEMENT
K023103
DePuy Orthopaedics, Inc.
Orthopedic · 376d
Cleared May 22, 2003
CEMEX SYSTEM FAST
K031430
Exactech, Inc.
Orthopedic · 16d
Cleared May 06, 2003
SURGICAL SIMPLEX P WITH TOBRAMYCIN
K014199
Howmedica Osteonics Corp.
Orthopedic · 501d
Cleared Feb 13, 2003
SMARTSET HV BONE CEMENT
K023012
DePuy Orthopaedics, Inc.
Orthopedic · 156d
Cleared Jul 24, 2002
CEMVAC ULTRA PRE-PACKED WITH DEPUY 1 BONE CEMENT
K021499
DePuy Orthopaedics, Inc.
Orthopedic · 76d
Cleared Jun 12, 2002
CEMEX RX, CEMEX ISOPLASTIC & CEMEX XL
K021715
Exactech, Inc.
Orthopedic · 20d