510(k) K020069 ยท HBB Motor, Drill, Pneumatic
MEDTRONIC MIDA REX LEGEND SYSTEM, MIDAS REX LEGEND PNEUMATIC HIGH SPEED SYSTEM OR LEGEND SYSTEM
| Applicant | Medtronic Midas Rex, Fort Worth TX, US |
| Decision | Substantially Equivalent, Mar 18, 2002 |
| Received | Jan 9, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020069
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 4, 2016 | Medtronic Sofamor Danek Usa, Inc - Dallas Distribution Medtronic Midas Rex Dissecting Tool Legend 10 cm 4mm BA DIAM.
Intended for use in neurosurgery. Terminated |
HBB | None listed |
| Oct 21, 2015 | Medtronic Sofamor Danek Usa, Inc - Dallas Distribution Tool Legend 16cm 2.4 mm wire pass for Midas Rex Legend Dissecting Tool. Used by surgeons to drill holes. Terminated |
HBB | None listed |
| Dec 17, 2009 | Medtronic Sofamor Danek Usa, Inc - Dallas Distribution Medtronic Midas Rex Legend Footed Attachment, AF01.
Intended for use with all Legend and Legend EHS motors for general surgery including maxillofacial , craniofacial and sternotomy applications. Terminated |
HBB | None listed |
| Aug 23, 2008 | Medtronic Powered Surgical Solutions Medtronic Midas Rex Legend tapered dissecting tool, Model F2/8TA23
Medtronic Powered Surgical Solutions, Forth Worth, TX
Intended for use in Spinal, Cranial, Orthopedic, General Surgical and Plastic Terminated |
HBB | None listed |
| Sep 21, 2005 | Power Surgical Solutions Medtronic Midas Rex Classic, GS and Legend dissecting tools manufactured by Medtronic Inc. Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, tX 76137 USA, Rx only, Sterile, Single Use O Terminated |
GET | None listed |
| Aug 3, 2005 | Medtronic Powered Surgical Solutions Medtronic MIDAS REX Legend High Speed Pneumatic System, Gold Touch Motor. Manufactured by Medtronic, Inc. Powered Surgical Solutions, 4620 North Beach Street, Fort Worth, TX 76137. Terminated |
HBB | None listed |
| Dec 4, 2004 | Power Surgical Solutions Medtronic Midas Rex Legend High Speed Pneumatic System Terminated |
HBB | None listed |
| Nov 20, 2004 | Power Surgical Solutions Medtronic Midas Rex Legend Lubricant/ Diffuser Cartridge Catalog number PA100-A, manufactured by Medtronic Powered Surgical Solutions, Fort Worth, Texas Terminated |
HBB | None listed |
| Jan 9, 2003 | Medtronics Midas Rex Legend Lubricant System (Legend Gold, Gold Touch and Platinum motors and Legend Lubricant/Diffuser cartridge) Terminated |
HBB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.