Spinal USA
Brandon, MS, US
Spinal USA appears in FDA device records in Brandon, MS. FDA records list 24 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 24
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 24 510(k) clearances for Spinal USA between 2006 and 2013. The busiest year on record is 2009, with 6. The most recent is 2013, with 5.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 3 |
| 2007 | 2 |
| 2008 | 3 |
| 2009 | 6 |
| 2011 | 2 |
| 2012 | 3 |
| 2013 | 5 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K132029 | VAULT-C INTERVERTEBRAL BODY FUSION DEVICE | OVE | Substantially Equivalent | |
| K130863 | FACET SCREW SYSTEM | MRW | Substantially Equivalent | |
| K131343 | REFORM PEDICLE SCREW SYSTEM | MNI | Substantially Equivalent | |
| K130279 | REFORM PEDICLE SCREW SYSTEM | MNI | Substantially Equivalent | |
| K130445 | VAULT ALIF SYSTEM | OVD | Substantially Equivalent | |
| K122931 | S-LOK PSS SYSTEM | MNI | Substantially Equivalent | |
| K121172 | REFORM PEDICLE SCREW SYSTEM | MNI | Substantially Equivalent | |
| K112748 | SLIMPLICITY SOLO ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K112025 | SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM | KWP | Substantially Equivalent | |
| K103369 | VAULT ALIF SYSTEM | OVD | Substantially Equivalent | |
| K092659 | SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25 | KWQ | Substantially Equivalent | |
| K092193 | SPINAL USA INTERBODY CAGES | MAX | Substantially Equivalent | |
| K092128 | MODIFICATION TO: PSS SYSTEM | MNI | Substantially Equivalent | |
| K091044 | SPINAL USA ANTERIOR LUMBAR PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K083118 | SPINAL USA ANTERIOR CERVICAL INTERBODY FUSION DEVICE | ODP | Substantially Equivalent | |
| K090033 | MODIFICATION TO: PSS SYSTEM | MNI | Substantially Equivalent | |
| K081196 | SPINAL USA VBR SYSTEM | MAX | Substantially Equivalent | |
| K080314 | SPINAL USA INTERBODY FUSION DEVICE | MAX | Substantially Equivalent | |
| K073240 | PSS SYSTEM | MNI | Substantially Equivalent | |
| K070922 | MODIFICATION TO SPINAL USA VBR SYSTEM | KWQ | Substantially Equivalent | |
| K071438 | PSS SYSTEM | MNI | Substantially Equivalent | |
| K061752 | SPINAL USA VBR SYSTEM | MQP | Substantially Equivalent | |
| K060025 | SLIMPLICITY ANTERIOR CERVICAL PLATE SYSTEM | KWQ | Substantially Equivalent | |
| K060132 | SPINAL USA CEMENT RESTRICTOR SYSTEM | JDK | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KWPAppliance, Fixation, Spinal Interlaminal
- KWQAppliance, Fixation, Spinal Intervertebral Body
- ODPIntervertebral Fusion Device With Bone Graft, Cervical
- MAXIntervertebral Fusion Device With Bone Graft, Lumbar
- OVEIntervertebral Fusion Device With Integrated Fixation, Cervical
- OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
- MNIOrthosis, Spinal Pedicle Fixation
- JDKProsthesis, Hip, Cement Restrictor
- MQPSpinal Vertebral Body Replacement Device
- MRWSystem, Facet Screw Spinal Device
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain