510(k) K092420 ยท MNI Orthosis, Spinal Pedicle Fixation
KRD1 PEDICLE SCREW SYSTEM
| Applicant | Spinefrontier, Inc., Beverly MA, US |
| Decision | Substantially Equivalent, Nov 19, 2009 |
| Received | Aug 6, 2009 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K092420
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 8, 2013 | SpineFrontier, Inc. Rev E PedFuse Return Screw Inserter, Part Number: 11-80030
Screw inserters are instruments which capture, hold and drive pedicle screw assemblies. There is a capturing feature that engages and holds Terminated |
HXX | None listed |
| Jul 16, 2013 | SpineFrontier, Inc. KRD1 PedFuse Rods, Model: IM80100-13 Rev B
Product Usage: Pedicle rods are cylindrical rods which act as a linking mechanism between pedicle screws. The rod sits with the pedicle screw tulip and th Terminated |
MNI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.