FDA 510(k) Applications Submitted by ABBOTT SPINE, INC.

FDA 510(k) Number Submission Date Device Name Applicant
K090060 01/09/2009 NEXLINK OCT SYSTEM, MODEL 7000 SERIES ABBOTT SPINE, INC.
K082032 07/17/2008 SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310) ABBOTT SPINE, INC.
K072672 09/21/2007 SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIES ABBOTT SPINE, INC.
K060009 01/03/2006 ABBOTT SPINE UNIVERSAL CLAMP SYSTEM ABBOTT SPINE, INC.
K052638 09/26/2005 ABBOTT SPINE, INC. SPINNAKER SYSTEM ABBOTT SPINE, INC.
K081622 06/10/2008 UNIVERSAL CLAMP STAINLESS STEEL SYSTEM ABBOTT SPINE, INC.
K073202 11/13/2007 ARDIS SPACER ABBOTT SPINE, INC.
K060634 03/09/2006 NEX-LINK SPINAL FIXATION SYSTEM ROD TO ROD CONNECTORS, MODELS 725, 726 SERIES ABBOTT SPINE, INC.
K052072 08/01/2005 THE SC-ACUFIX ANT-CER DYNAMIC CERVICAL PLATE SYSTEM SINGLE LEVEL PLATES ABBOTT SPINE, INC.
K052247 08/18/2005 NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX ABBOTT SPINE, INC.
K062505 08/28/2006 NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES ABBOTT SPINE, INC.
K052566 09/19/2005 NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY ABBOTT SPINE, INC.
K071174 04/27/2007 PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS ABBOTT SPINE, INC.


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact