510(k) K031855 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM
| Applicant | Spinal Concepts, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Sep 17, 2003 |
| Received | Jun 16, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K031855
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2006 | Abbott Spine TraXis Vue Spinal Implant System, Part #2601-090921 Terminated |
MQP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.