510(k) K092624 ยท NKB Thoracolumbosacral Pedicle Screw System
FIREBIRD SPINAL FIXATION SYSTEM
| Applicant | Blackstone Medical, Inc., Wayne NJ, US |
| Decision | Substantially Equivalent, Sep 25, 2009 |
| Received | Aug 26, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K092624
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 7, 2011 | Orthofix, Inc. Ratcheting Torque Limiting Handle, Catalog Number 52-1012, Orthofix Spinal Implants, Firebird Spinal Fixation System, Firebird Spinal Fixation System DDD Instrument Case.
Product is intended for use Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.