510(k) K133221 ยท NKB Thoracolumbosacral Pedicle Screw System
ARSENAL SPINAL FIXATION SYSTEM
| Applicant | Alphatec Spine, Inc., Carlsbad CA, US |
| Decision | Substantially Equivalent, Mar 13, 2014 |
| Received | Oct 18, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133221
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 5, 2017 | Alphatec Spine, Inc. Arsenal Spinal Fixation System, Set Screw, Part No. 47027
Product Usage:
The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for t Terminated |
NKB | None listed |
| Nov 16, 2016 | Alphatec Spine, Inc. Arsenal Spinal Fixation System, Set Screw, Part No. 47127
Product Usage: Usage:
The Arsenal Spinal Fixation System is intended for posterior, non-cervical, spinal fixation as an adjunct to fusion for Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.