Company
Medtronic Sofamor Danek Instrument Manufacturing
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
39recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 8, 2007 | Medtronic Sofamor Danek Instrument Manufacturing Rocker Reducer, part of the SiLo Spinal System, REF 8880014, Rx only, Material: Stainless Steel, qty: 1 ea, non-sterile, Medtronic Sofamor Danek, 1800 Pyramid Place Memphis, TN 38132, USA, Manufact Terminated |
MNI | K042210 |
| Oct 19, 2006 | Medtronic Sofamor Danek Instrument Manufacturing Implant Hollow Reamer, 14 mm, REF 8951405, Medtronic Sofamor Danek, Manufactured at: Bartlett Tennessee USA, Rx only. The product is a bone reamer which is sterilized at the point of use (hospital/c Terminated |
HTO | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 22mm x 9cm stainless steel tubular retractor, Part No. 9569736 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 22mm x 8cm stainless steel tubular retractor, Part No. 9569735 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 22mm x 7cm stainless steel tubular retractor, Part No. 9569734 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 22mm x 6cm stainless steel tubular retractor, Part No. 9569733 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 22mm x 5cm stainless steel tubular retractor, Part No. 9569732 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 22mm x 4cm stainless steel tubular retractor, Part No. 9569731 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 22mm x 3cm stainless steel tubular retractor, Part No. 9569730 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 20mm x 9cm stainless steel tubular retractor, Part No. 9569726 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 20mm x 8cm stainless steel tubular retractor, Part No. 9569725 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 20mm x 7cm stainless steel tubular retractor, Part No. 9569724 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 20mm x 6cm stainless steel tubular retractor, Part No. 9569723 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 20mm x 5cm stainless steel tubular retractor, Part No. 9569722 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 20mm x 4cm stainless steel tubular retractor, Part No. 9569721 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 20mm x 3cm stainless steel tubular retractor, Part No. 9569720 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 18mm x 9cm stainless steel tubular retractor, Part No. 9569686 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 18mm x 8cm stainless steel tubular retractor, Part No. 9569685 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 18mm x 7cm stainless steel tubular retractor, Part No. 9569684 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 18mm x 6cm stainless steel tubular retractor, Part No. 9569683 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 18mm x 5cm stainless steel tubular retractor, Part No. 9569682 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 18mm x 4cm stainless steel tubular retractor, Part No. 9569681 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 18mm x 3cm stainless steel tubular retractor, Part No. 9569680 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 16mm x 9cm stainless steel tubular retractor, Part No. 9569676 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 16mm x 8cm stainless steel tubular retractor, Part No. 9569675 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 16mm x 7cm stainless steel tubular retractor, Part No. 9569674 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 16mm x 6cm stainless steel tubular retractor, Part No. 9569673 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 16mm x 5cm stainless steel tubular retractor, Part No. 9569672 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 16mm x 4cm stainless steel tubular retractor, Part No. 9569671 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 16mm x 3cm stainless steel tubular retractor, Part No. 9569670 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 14mm x 9cm stainless steel tubular retractor, Part No. 9569666 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 14mm x 8cm stainless steel tubular retractor, Part No. 9569665 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 14mm x 7cm stainless steel tubular retractor, Part No. 9569664 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 14mm x 6cm stainless steel tubular retractor, Part No. 9569663 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 14mm x 5cm stainless steel tubular retractor, Part No. 9569662 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 14mm x 4cm stainless steel tubular retractor, Part No. 9569661 Terminated |
LXH | None listed |
| Apr 12, 2006 | Medtronic Sofamor Danek Instrument Manufacturing METRx II Tube, 14mm x 3cm stainless steel tubular retractor, Part No. 9569660 Terminated |
LXH | None listed |
| Feb 23, 2006 | Medtronic Sofamor Danek Instrument Manufacturing Holt Probe Round Straight Terminated |
HXX | None listed |
| Dec 28, 2005 | Medtronic Sofamor Danek Instrument Manufacturing Atlantis Anterior Cervical Plate System Screw Driver, Part number 876-482 Terminated |
HXX | None listed |