510(k) K041808 ยท KWP Appliance, Fixation, Spinal Interlaminal
ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM
| Applicant | Endius, Inc., Plainville MA, US |
| Decision | Substantially Equivalent, Oct 1, 2004 |
| Received | Jul 6, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K041808
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 12, 2014 | Zimmer, Inc. Zimmer Title 2 Bone Screw Remover Instrument, Part Number ET1093-01 Rx Only, Non-Sterile.
The Screw Remover is a component of the Endius TITLE 2 Polyaxial Spinal System, used for posterior lumbar fus Terminated |
KWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.