Company ยท US
Abbott Spine
FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2009. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
16recalls (0 in 12 months)
9recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | 7 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 6 |
| MNI | Orthosis, Spinal Pedicle Fixation | 5 |
| MQP | Spinal Vertebral Body Replacement Device | 3 |
| JDQ | Cerclage, Fixation | 2 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 2 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | 1 |
| KKX | Drape, Surgical, Antimicrobial | 1 |
| KNW | Instrument, Biopsy | 1 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 2, 2009 | K090060 | NEXLINK OCT SYSTEM, MODEL 7000 SERIES Abbott Spine, Inc. | KWP |
| Oct 6, 2008 | K082032 | SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310) Abbott Spine, Inc. | NKB |
| Aug 29, 2008 | K081622 | UNIVERSAL CLAMP STAINLESS STEEL SYSTEM Abbott Spine, Inc. | JDQ |
| Jan 30, 2008 | K073202 | ARDIS SPACER Abbott Spine, Inc. | MAX |
| Nov 28, 2007 | K072672 | SEQUOIA SPINAL SYSTEM, MODEL 3300 SERIES Abbott Spine, Inc. | NKB |
| Jul 25, 2007 | K071174 | PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS Abbott Spine, Inc. | NKB |
| Sep 26, 2006 | K062505 | NEX-LINK SPINAL FIXATION SYSTEM OFFSET CONNECTORS, 2121-XX SERIES Abbott Spine, Inc. | MNI |
| Mar 31, 2006 | K060634 | NEX-LINK SPINAL FIXATION SYSTEM ROD TO ROD CONNECTORS, MODELS 725, 726 SERIES Abbott Spine, Inc. | MNI |
| Mar 6, 2006 | K060009 | ABBOTT SPINE UNIVERSAL CLAMP SYSTEM Abbott Spine, Inc. | JDQ |
| Jan 6, 2006 | K052566 | NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY Abbott Spine, Inc. | MNI |
| Nov 7, 2005 | K052638 | ABBOTT SPINE, INC. SPINNAKER SYSTEM Abbott Spine, Inc. | KNW |
| Sep 14, 2005 | K052247 | NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX Abbott Spine, Inc. | KWP |
| Aug 29, 2005 | K052072 | THE SC-ACUFIX ANT-CER DYNAMIC CERVICAL PLATE SYSTEM SINGLE LEVEL PLATES Abbott Spine, Inc. | KWQ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 5, 2008 | Abbott Spine PathFinder Cannulated T-Handle Bone Awl, Part Number 1155-2; distributed by Abbott Spine, Inc., Austin, TX 78727. Terminated |
NKB | K030625 K071174 |
| Sep 1, 2008 | Abbott Spine PathFinder Spinal Fixation System T-Handle Driver; Part 2151-7 (13" shaft); Non-sterile, Reusable Instrument; manufactured by Abbott Spine, Austin, TX 78727. Terminated |
MNI | K030625 K071174 |
| Sep 1, 2008 | Abbott Spine InCompass Spinal Fixation System T-Handle Driver; Part #2151-4 (9.5" shaft) and 2151-5 (13" shaft); Non-sterile, Reusable Instrument; manufactured by Abbott Spine, Austin, TX 78727. Terminated |
MNI | K021564 K023644 |
| Jul 23, 2008 | Abbott Spine Sequoia Spinal System Surgical Kits; Pedicle screw spinal system; Non-sterile (kits intended to be sterilized prior to use); Rx Only;
The Sequoia Spinal System is designed to aid in the surgical cor Terminated |
NKB | K072672 |
| Feb 13, 2008 | Abbott Spine Comfort T-Handle Hudson Connector with Impactor Cap; Part #1006-1; handle is component of the following consignment surgical kits: Harmony 2700-0001-PL, Harmony 2700-0009-PL, Harmony 2900-0001-PL, Har Terminated |
GZT | K050706 |
| Oct 2, 2007 | Abbott Spine PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60. Terminated |
NKB | K030625 |
| Oct 2, 2007 | Abbott Spine PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50. Terminated |
NKB | K030625 |
| Jan 17, 2007 | Abbott Spine TraXis Fixed Rasp in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; for use with TraXis vertebral body replacement system Terminated |
MQP | None listed |
| Jan 17, 2007 | Abbott Spine TraXis Fixed Trial in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; part of TraXis vertebral body replacement system Terminated |
MQP | None listed |
| Jun 17, 2006 | Abbott Spine Stericover/ Sterile Disposible Polyethylene Drape ---Universal Video Camera/ Laser Arm Equipment Cover; 7'' x 96''. Terminated |
KKX | None listed |
| Feb 7, 2006 | Abbott Spine TraXis Vue Spinal Implant System, Part #2601-090921 Terminated |
MQP | K031855 |
| Dec 17, 2005 | Abbott Spine SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix Ant-Cer Anterior Cervical Plating Systems. Terminated |
KWQ | None listed |
| Dec 17, 2005 | Abbott Spine SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix ThinLine Anterior Cervical Plating Systems. Terminated |
KWQ | None listed |
| Dec 17, 2005 | Abbott Spine SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix Corpectomy Anterior Cervical Plating Systems. Terminated |
KWQ | None listed |
| Dec 17, 2005 | Abbott Spine SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix SlimLine and SlimLine Hybrid Anterior Cervical Plating Systems. Terminated |
KWQ | None listed |
| Dec 17, 2005 | Abbott Spine SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix SlimLine, SlimLine Hybrid, Corpectomy, ThinLine and Ant-Cer Anterior Cervical Plating Systems. Terminated |
KWQ | K013979 K024326 +1 |