Company ยท US
Spinal USA
FDA 510(k) clearances and medical device recalls filed under this name, 2006 to 2013. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| MNI | Orthosis, Spinal Pedicle Fixation | 8 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 5 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | 3 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | 2 |
| JDK | Prosthesis, Hip, Cement Restrictor | 1 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 1 |
| MQP | Spinal Vertebral Body Replacement Device | 1 |
| MRW | System, Facet Screw Spinal Device | 1 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | 1 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 25, 2013 | K132029 | VAULT-C INTERVERTEBRAL BODY FUSION DEVICE Spinal USA | OVE |
| Aug 9, 2013 | K130863 | FACET SCREW SYSTEM Spinal USA | MRW |
| Jul 24, 2013 | K131343 | REFORM PEDICLE SCREW SYSTEM Spinal USA | MNI |
| Jun 20, 2013 | K130279 | REFORM PEDICLE SCREW SYSTEM Spinal USA | MNI |
| Apr 25, 2013 | K130445 | VAULT ALIF SYSTEM Spinal USA | OVD |
| Nov 20, 2012 | K122931 | S-LOK PSS SYSTEM Spinal USA | MNI |
| Aug 8, 2012 | K121172 | REFORM PEDICLE SCREW SYSTEM Spinal USA | MNI |
| Jul 11, 2012 | K112748 | SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM Spinal USA, LLC | KWQ |
| Sep 15, 2011 | K112025 | SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM Spinal USA | KWP |
| Apr 4, 2011 | K103369 | VAULT ALIF SYSTEM Spinal USA | OVD |
| Nov 17, 2009 | K092659 | SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25 Spinal USA | KWQ |
| Sep 25, 2009 | K092193 | SPINAL USA INTERBODY CAGES Spinal USA | MAX |
| Sep 14, 2009 | K092128 | MODIFICATION TO: PSS SYSTEM Spinal USA | MNI |
| Jul 9, 2009 | K091044 | SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM Spinal USA | KWQ |
| May 27, 2009 | K083118 | SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE Spinal USA | ODP |
| May 6, 2009 | K090033 | MODIFICATION TO: PSS SYSTEM Spinal USA | MNI |
| Oct 16, 2008 | K081196 | SPINAL USA VBR SYSTEM Spinal USA | MAX |
| May 13, 2008 | K080314 | SPINAL USA INTERBODY FUSION DEVICE Spinal USA | MAX |
| Mar 20, 2008 | K073240 | PSS SYSTEM Spinal USA | MNI |
| Sep 19, 2007 | K070922 | MODIFICATION TO SPINAL USA VBR SYSTEM Spinal USA | KWQ |
| Aug 21, 2007 | K071438 | PSS SYSTEM Spinal USA | MNI |
| Aug 15, 2006 | K061752 | SPINAL USA VBR SYSTEM Spinal USA | MQP |
| Apr 18, 2006 | K060025 | SLIMPLICITY ANTERIOR CERVICAL PLATE SYSTEM Spinal USA | KWQ |
| Mar 16, 2006 | K060132 | SPINAL USA CEMENT RESTRICTOR SYSTEM Spinal USA | JDK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||