510(k) K092531 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
SPINE360 ANTERIOR CERVICAL PLATE SYSTEM
| Applicant | Spine360, Austin TX, US |
| Decision | Substantially Equivalent, Feb 4, 2010 |
| Received | Aug 18, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092531
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 13, 2017 | Amendia, Inc dba Spinal Elements Piranha Screw 4.0 x 12mm, used in Piranha Surgical Plate System
The Piranha Surgical Plate System is intended to provide stabilization of the cervical vertebrae for various indications as part of the Terminated |
KWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.