510(k) K073708 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
FIXED, VARIABLE & CORPECTOMY CERVICAL PLATE SYSTEM
| Applicant | Precision Surgery , Ltd., Chesterland OH, US |
| Decision | Substantially Equivalent, Jun 3, 2008 |
| Received | Dec 31, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K073708
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 23, 2012 | Captiva Spine, Inc Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part:
"***Part Number CP40012***12mm Drill Bit***Lot Number 89427-2 R***"
"***Part Number CP40014* Terminated |
KWQ | None listed |
| May 23, 2012 | Captiva Spine, Inc Accessories for the Captiva Spine SmartLOX Cervical Plate System. Products are labeled in part:
"***Part Number CP50150***Single Barrel Variable Drill Guide***Lot Number 1500705A or Lot Number Terminated |
KWQ | None listed |
| May 14, 2012 | Captiva Spine, Inc Instructions For Use: "***SmartLOX***Instructions for Use Cervical Plate System***STERILIZATION***The SmartLOX Cervical Plate System components are supplied clean and not sterile. All implants and i Terminated |
KWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.