510(k) K070300 ยท KWP Appliance, Fixation, Spinal Interlaminal
EXPEDIUM SFX CROSS CONNECTOR SYSTEM
| Applicant | Depuy Spine, Inc., Raynham MA, US |
| Decision | Substantially Equivalent, Apr 10, 2007 |
| Received | Jan 31, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070300
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2009 | DePuy Spine, Inc. DePuy Spine Expedium SFX Cross Connector System Torque Driver Shaft, Non-Sterile, REF: 2894-10-300.
Intended to provide immobilization and stabilization of spinal segments in skeletally mature patien Terminated |
KWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.