510(k) K081684 ยท NKB Thoracolumbosacral Pedicle Screw System
BLACKSTONE PEDICLE SCREW SYSTEM
| Applicant | Blackstone Medical, Inc., Wayne NJ, US |
| Decision | Substantially Equivalent, Sep 15, 2008 |
| Received | Jun 17, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081684
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 28, 2014 | Orthofix, Inc. Orthofix Firebird Spinal Fixation System Instrumentation Modular Screw Driver,
Product Usage: The Modular Screw Driver is used for inserting a modular bone screw into the pedicle during a spinal f Terminated |
KWP | None listed |
| Mar 16, 2011 | Orthofix Inc BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Bone Screw, Self Tapping, Cannulated. BLACKSTONE Medical Inc. Firebird Spinal Fixation System 6.5mm x 30mm Multi-Axial Screw, Self Terminated |
NKB | None listed |
| Mar 8, 2011 | Orthofix Inc ORTHOFIX Firebird Spinal Fixation System, Pedicle Screw Spinal System, Reduction Case, Part #68-0111, Lot #16518-LC18.
Intended for use in conjunction with Multi-Axial Reduction Screw Assemblies. Dur Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.