Company ยท US
Synthes Spine
FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 2012. Name variants (Inc, Corp, punctuation) are merged.
54510(k) clearances (0 in 12 months)
13recalls (0 in 12 months)
13recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 13 |
| NKB | Thoracolumbosacral Pedicle Screw System | 10 |
| MNI | Orthosis, Spinal Pedicle Fixation | 7 |
| MQP | Spinal Vertebral Body Replacement Device | 6 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 5 |
| HRS | Plate, Fixation, Bone | 4 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 4 |
| NQP | Posterior Metal/Polymer Spinal System, Fusion | 4 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 2 |
| NPQ | Test, Factor V Leiden Mutations, Genomic Dna Pcr | 2 |
| OMR | Vessel Guard Or Cover | 2 |
| HAW | Neurological Stereotaxic Instrument | 1 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 17, 2012 | K122211 | SYNTHES NAVIGABLE PEDICLE PREPARATION INSTRUMENTS Synthes Spine | HAW |
| Jul 31, 2012 | K120838 | SYNTHES MATRIX SYSTEM Synthes Spine | NKB |
| Jul 25, 2012 | K121852 | SYNTHES ZERO-P VARIABLE ANGLE (VA) Synthes Spine Co.Lp | OVE |
| Jun 14, 2012 | K111048 | SYNTHES SCOUT TACK FIXATION Synthes Spine | OMR |
| May 18, 2012 | K120928 | SYNTHES MATRIX SYSTEM Synthes Spine | NKB |
| May 14, 2012 | K120571 | SYNTHES USS CONNECTOR Synthes Spine | NKB |
| Feb 1, 2012 | K113149 | SYNTHES USS CONNECTORS Synthes Spine | MNI |
| Dec 21, 2011 | K113044 | SYNTHES MIRS Synthes Spine | NKB |
| Dec 12, 2011 | K112459 | SYNTHES ZERO-P Synthes Spine Co.Lp | OVE |
| Nov 18, 2011 | K111358 | SYNTHES USS Synthes Spine | NKB |
| Nov 7, 2011 | K112068 | SYNTHES ZERO-P VARIABLE ANGLE (VA) Synthes Spine Co.Lp | OVE |
| Oct 20, 2011 | K103320 | SYNTHES XRL Synthes Spine Co.Lp | MQP |
| Feb 18, 2011 | K103558 | SYNTHES SCOUT VESSEL GUARD Synthes Spine | OMR |
| Jan 5, 2011 | K103287 | SYNTHES 6.0 COCR AND CPT TI-3 RODS Synthes Spine | NKB |
| Dec 20, 2010 | K093762 | SYNTHES ZERO-P Synthes Spine | OVE |
| Aug 5, 2010 | K100952 | MODIFICATION TO SYNTHES MATRIX SYSTEM Synthes Spine | NKB |
| May 13, 2010 | K100089 | SYNTHES T-PAL SPACER Synthes Spine | MAX |
| Jul 10, 2009 | K091159 | SYNTHES ORACLE PLATE Synthes Spine | KWQ |
| May 21, 2009 | K090549 | SYNTHES SYNAPSE TRANSCONNECTOR Synthes Spine | KWP |
| Dec 11, 2008 | K082914 | CLAMPFIX Synthes Spine | NKB |
| Nov 24, 2008 | K082572 | USS ILIOSACRAL, USS POLYAXIAL Synthes Spine | NKB |
| Sep 2, 2008 | K081568 | ANTEGRA-T Synthes Spine Co.Lp | KWQ |
| May 23, 2008 | K080020 | ARCOFIX Synthes Spine Co.Lp | KWQ |
| Feb 11, 2008 | K072981 | SYNTHES ZERO-P Synthes Spine Co.Lp | OVE |
| Jan 10, 2008 | K072434 | SYNTHES OC FUSION AND SYNAPSE SYSTEMS Synthes Spine Co.Lp | MNI |
| Dec 26, 2007 | K072791 | ORACLE SPACER, OPAL SPACER Synthes Spine | MAX |
| Nov 30, 2007 | K071667 | SYNTHES VECTRA-ONE SYSTEM Synthes Spine | KWQ |
| Oct 12, 2007 | K072253 | SYNFIX-LR SPACER Synthes Spine Co.Lp | OVD |
| Jun 8, 2007 | K070573 | SYNAPSE SYSTEM Synthes Spine Co.Lp | MNI |
| Apr 3, 2007 | K062083 | SYNFIX -LR Synthes Spine Co.Lp | MQP |
| Jan 31, 2007 | K062933 | SYNTHES ORACLE SPACER Synthes Spine Co.Lp | MQP |
| Nov 14, 2006 | K063158 | SYNTHES ANTEGRA SYSTEM Synthes Spine Co.Lp | KWQ |
| Sep 6, 2006 | K053418 | SYNTHES OC FUSION SYSTEM Synthes Spine Co.Lp | KWP |
| Aug 18, 2006 | K061891 | SYNEX II Synthes Spine Co.Lp | MQP |
| Feb 13, 2006 | K053508 | SYNFIX-LR Synthes Spine Co.Lp | MQP |
| Dec 7, 2005 | K052151 | SYNTHES PANGEA MONOAXIAL SYSTEM Synthes Spine Co.Lp | NKB |
| Sep 9, 2005 | K051665 | SYNTHES VECTRA-T SYSTEM Synthes Spine | KWQ |
| Mar 24, 2005 | K050451 | SYNTHES VECTRA SYSTEM Synthes Spine Co.Lp | KWQ |
| Oct 1, 2004 | K041389 | SYNTHES CONTOURED SYNMESH SPACER Synthes Spine | MQP |
| Apr 1, 2004 | K032534 | SYNTHES AFS Synthes Spine | NQW |
| Apr 22, 2002 | K020244 | SYNTHES THORACOLUMBAR SPINE LOCKING PLATE (TSLP) Synthes Spine | KWQ |
| Jul 20, 2000 | K001864 | SYNTHES CERVIFIX SYSTEM Synthes Spine | KWQ |
| Mar 29, 2000 | K000742 | SYNTHES ANTERIOR CSLP SYSTEM Synthes Spine | KWQ |
| Mar 15, 2000 | K000536 | SYNTHES ANTERIOR CSLP SYSTEM Synthes Spine | KWQ |
| Mar 10, 2000 | K000450 | MODIFICATION TO SYNTHES USS Synthes Spine | MNI |
| Feb 8, 2000 | K992739 | CLICK'X Synthes Spine | MNH |
| Aug 27, 1999 | K991089 | SYNTHES CERVIFIX SYSTEM Synthes Spine | KWP |
| Mar 30, 1999 | K990745 | MODIFICATION TO SYNTHES UNIVERSAL SPINAL SYSTEM Synthes Spine | MNI |
| Jan 19, 1999 | K984612 | SYNTHES SPINE POSTERIOR UNIVERSAL SYSTEM Synthes Spine | MNI |
| Oct 21, 1998 | K982987 | SYNTHES POSTERIOR UNIVERSAL SPINAL SYSTEM Synthes Spine | MNI |
Newest 50 of 54.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 10, 2009 | Synthes Spine Synthes Zero-P StarDrive Screwdriver Shaft, T8, self-retaining, quick coupling, for use in spinal fusion surgery. Catalog # 03.617.902 Technique Guide. Terminated |
ODP | K072981 |
| Jun 1, 2009 | Synthes Spine Synthes InSitu Bender Cutter Kit Narrow Sterile Catalog number 530.522S, used with Synthes Rapid Resorbable Fixation System for craniofacial skeleton fracture repair and reconstructive procedures. Terminated |
HRS | K021458 |
| Jun 1, 2009 | Synthes Spine Synthes InSitu Bender Cutter Kit Wide Sterile Catalog number 530.521S, used with Synthes Rapid Resorbable Fixation System for craniofacial skeleton fracture repair and reconstructive procedures. Terminated |
HRS | K021458 |
| May 29, 2009 | Synthes Spine Square Nut MR Safe, Catalog Number 03.311.060.
The Square Nut MR Safe is used in conjunction with Synthes Distraction Osteogenesis Ring Systems. It can be used to secure components together or as a Terminated |
KTT | K051600 |
| May 21, 2009 | Synthes Spine In Situ Bender Cutter Kit Narrow Sterile, Catalog number 530.522S.
Used with Synthes' Rapid Resorbable Fixation System which is intended for use in fracture repair and reconstructive procedures of th Terminated |
HRS | K021458 |
| May 21, 2009 | Synthes Spine In Situ Bender Cutter Kit Wide Sterile, Catalog number 530.521S
Used with Synthes' Rapid Resorbable Fixation System which is intended for use in fracture repair and reconstructive procedures of the c Terminated |
HRS | K021458 |
| Feb 3, 2009 | Synthes Spine NFlex Stabilization System 150 mm, Catalog number NF60150-1.
spinal fusion surgery Terminated |
NPQ | K072685 |
| Feb 3, 2009 | Synthes Spine NFlex Stabilization System 200 mm, Catalog number NF60020-1.
spinal fusion surgery Terminated |
NPQ | K072685 |
| Feb 3, 2009 | Synthes Spine TI N-Hance Rod 150 mm Sterile, Catalog number 04.600.715.02S
spinal fusion surgery Terminated |
NQP | K072685 |
| Feb 3, 2009 | Synthes Spine N-Hance System 150 mm, Catalog number NH60150-1.
spinal fusion surgery Terminated |
NQP | K072685 |
| Feb 3, 2009 | Synthes Spine NFix II System 200 mm, Catalog number NX60200-1.
spinal fusion surgery Terminated |
NQP | K061774 |
| Feb 3, 2009 | Synthes Spine NFix II System 150 mm, Catalog number NX60150-1
spinal fusion surgery Terminated |
NQP | K061774 |
| Jan 30, 2009 | Synthes Spine Low Profile U-Joint Driver for the SynFix Mini-Open System, Catalog number 03.802.231.
The Synthes SynFix LR is indicated for use in patients with degenerative disc disease (DDD) at one or two contig Terminated |
MAX | K072253 |