510(k) K072317 ยท NKB Thoracolumbosacral Pedicle Screw System
MODIFICATION TO:TSRH SPINAL SYSTEM
| Applicant | Medtronic Sofamor Danek USA, Inc., Memphis TN, US |
| Decision | Substantially Equivalent, Sep 18, 2007 |
| Received | Aug 20, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K072317
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 12, 2009 | Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK Medtronic TSRH 3DX Implant Set; SPS002058. Sets are unlabeled, but contain individually labeled 3Dx Splined Connectors in sizes small, medium and large.
The device is intended for orthosis, spinal Terminated |
MNI | None listed |
| Mar 12, 2009 | Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK Medtronic TSRH Spinal System, 3Dx Splined Connector, Small; Medtronic Sofamor Danek, Memphis, TN; REF 8351510.
The device is intended for orthosis, spinal pedicle fixation for degenerative disc disea Terminated |
MNI | None listed |
| Mar 12, 2009 | Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK Medtronic TSRH Spinal System, 3Dx Splined Connector, Medium; Medtronic Sofamor Danek, Memphis, TN; REF 8351511.
The device is intended for orthosis, spinal pedicle fixation for degenerative disc dise Terminated |
MNI | None listed |
| Mar 12, 2009 | Warsaw Orthopedic, Inc. dba Medtronic SOFAMOR DANEK Medtronic TSRH Spinal System, 3Dx Splined Connector, Large; Medtronic Sofamor Danek, Memphis, TN; REF 8351512.
The device is intended for orthosis, spinal pedicle fixation for degenerative disc disea Terminated |
MNI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.