NDN · Class II · 21 CFR 888.3027

FDA Product Code NDN: Cement, Bone, Vertebroplasty

Leading manufacturers include Arthrocare Corp., Stryker Corporation and Tecres S.P.A..

108
Total
108
Cleared
154d
Avg days
2004
Since
108 devices
97–108 of 108
Cleared Mar 17, 2006
SPINE-FIX BIOMIMETIC BONE CEMENT
K043593
Teknimed, S.A.
Orthopedic · 443d
Cleared Mar 13, 2006
EBI VERTEBROPLASTY SYSTEMS
K060148
Ebi, L.P.
Orthopedic · 53d
Cleared Jan 25, 2006
PARALLAX ACRYLIC RESIN CARTRIDGE WITH TRACERS
K053180
Arthrocare Corp.
Orthopedic · 72d
Cleared Nov 08, 2005
VERTEFIX VERTEBROPLASTY PROCEDURE SET
K042691
Cook, Inc.
Orthopedic · 405d
Cleared Jul 15, 2005
VERTEBROPLASTIC RADIOPAQUE BONE CEMENT
K043406
Depuy Spine, Inc.
Orthopedic · 217d
Cleared Jun 17, 2005
PARALLAX ACRYLIC RESIN WITH TRACERS TA
K050864
Arthrocare Corp.
Orthopedic · 73d
Cleared Jun 09, 2005
MENDEC SPINE
K042415
Tecres S.P.A.
Orthopedic · 275d
Cleared May 11, 2005
RADIOPAQUE BONE CEMENT
K043518
Cardinalhealth
Orthopedic · 142d
Cleared Jan 14, 2005
CONCORD Radiopaque Bone Cement
K042168
Globus Medical, Inc.
Orthopedic · 158d
Cleared Dec 27, 2004
PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003
K042947
Arthrocare Corp.
Orthopedic · 62d
Cleared Jul 07, 2004
KYPHX HV-R BONE CEMENT, MODEL C01A
K041584
Kyphon, Inc.
Orthopedic · 23d
Cleared Apr 01, 2004
KYPHX HV-R, MODEL C01A
K033801
Kyphon, Inc.
Orthopedic · 115d