510(k) K003836 ยท MQP Spinal Vertebral Body Replacement Device
SYNTHES SYNEX SPACER SYSTEM
| Applicant | Synthes, Paoli PA, US |
| Decision | Substantially Equivalent, May 29, 2001 |
| Received | Dec 12, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003836
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 9, 2009 | Synthes USA (HQ), Inc. Synthes USA, TI Synex (TM) II Central Body 14mm - 19mm, Catalog number 04.808.001.
Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due Terminated |
MQP | None listed |
| Nov 9, 2009 | Synthes USA (HQ), Inc. Synthes USA, TI Synex (TM) II Central Body 17mm - 25mm, Catalog number 04.808.002.
Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due Terminated |
MQP | None listed |
| Nov 9, 2009 | Synthes USA (HQ), Inc. Synthes USA, TI Synex (TM) II Central Body 21mm - 29mm, Catalog number 04.808.003.
Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due Terminated |
MQP | None listed |
| Nov 9, 2009 | Synthes USA (HQ), Inc. Synthes USA, TI Synex (TM) II Central Body 25mm - 33mm, Catalog number 04.808.004.
Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due Terminated |
MQP | None listed |
| Nov 9, 2009 | Synthes USA (HQ), Inc. Synthes USA, TI Synex (TM) II Central Body 29mm - 44mm, Catalog number 04.808.005.
Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due Terminated |
MQP | None listed |
| Nov 9, 2009 | Synthes USA (HQ), Inc. Synthes USA, TI Synex (TM) II Central Body 37mm - 52mm, Catalog number 04.808.006.
Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due Terminated |
MQP | None listed |
| Nov 9, 2009 | Synthes USA (HQ), Inc. Synthes USA, TI Synex (TM) II Central Body 45mm - 71mm, Catalog number 04.808.007.
Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due Terminated |
MQP | None listed |
| Nov 9, 2009 | Synthes USA (HQ), Inc. Synthes USA, TI Synex (TM) II Central Body 58mm - 84mm, Catalog number 04.808.008.
Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due Terminated |
MQP | None listed |
| Nov 9, 2009 | Synthes USA (HQ), Inc. Synthes USA, TI Synex (TM) II Central Body 71mm - 97mm, Catalog number 04.808.009.
Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due Terminated |
MQP | None listed |
| Nov 9, 2009 | Synthes USA (HQ), Inc. Synthes USA, TI Synex (TM) II Central Body 84mm - 110mm, Catalog number 04.808.010.
Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due Terminated |
MQP | None listed |
| Nov 9, 2009 | Synthes USA (HQ), Inc. Synthes USA, TI Synex (TM) II Central Body 97mm - 123mm, Catalog number 04.808.011.
Intended for use in the thoracolumbar spine (T1-L5) to replace a collapsed, damaged, or unstable vertebral body due Terminated |
MQP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.