LOD · Class II · 21 CFR 888.3027

FDA Product Code LOD: Bone Cement

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

72
Total
72
Cleared
167d
Avg days
2000
Since
72 devices
49–72 of 72
Cleared May 25, 2004
REFOBACIN -PALACOS G
K031673
Heraeus Kulzer GmbH & Co. KG
Orthopedic · 361d
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 Sep 23, 2003
PALACOS R
K030902
Heraeus Kulzer GmbH & Co. KG
Orthopedic · 183d
Cleared Sep 23, 2003
OSTEOPAL
K030903
Heraeus Kulzer GmbH & Co. KG
Orthopedic · 183d
Cleared Sep 23, 2003
PALAMED
K030904
Heraeus Medical GmbH Technology
Orthopedic · 183d
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 26, 2003
PALABOND
K022251
Heraeus Kulzer GmbH & Co. KG
Orthopedic · 229d
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
Cleared Feb 08, 2002
CONCERT RADIOPAQUE BONE CEMENT
K013755
Immedica, Inc.
Orthopedic · 87d
Cleared Dec 19, 2001
GENERATION 4 BONE CEMENT
K993836
Biomet, Inc.
Orthopedic · 768d
Cleared Oct 30, 2001
PALAMED BONE CEMENT
K010586
Merck Biomaterial GmbH
Orthopedic · 245d
Cleared Feb 08, 2001
CEMEX SYSTEM GUN APPLICATION VERSION
K000943
Exactech, Inc.
Orthopedic · 322d
Cleared Jan 26, 2001
SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT AND ACM AND MIXEVACII
K002652
Stryker Corp.
Orthopedic · 154d
Cleared Dec 11, 2000
VERSABOND BONE CEMENT
K001160
Smith & Nephew, Inc.
Orthopedic · 245d