510(k) K002082 ยท KWP Appliance, Fixation, Spinal Interlaminal
SPEEDLINK TRANSVERSE CONNECTOR
| Applicant | Spinal Concepts, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Oct 6, 2000 |
| Received | Jul 10, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K002082
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 8, 2010 | Zimmer Inc. SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S Terminated |
KWP | None listed |
| Oct 8, 2010 | Zimmer Inc. SpeedLink 5.5 Transverse Connector Medium 43-51mm, non-sterile, 1302-55M Terminated |
KWP | None listed |
| Oct 8, 2010 | Zimmer Inc. SpeedLink 5.5 Transverse Connector Long 50-65mm, non-sterile, 1302-55L Terminated |
KWP | None listed |
| Oct 8, 2010 | Zimmer Inc. SpeedLink 5.5 Transverse Connector X-Long 60-75mm, non-sterile, 1302-55XL Terminated |
KWP | None listed |
| Oct 8, 2010 | Zimmer Inc. SpeedLink 6.0 Transverse Connector Short 39.5-44mm, non-sterile, 1304-60S Terminated |
KWP | None listed |
| Oct 8, 2010 | Zimmer Inc. SpeedLink 6.0 Transverse Connector Long 50-60mm, non-sterile, 1304-60L Terminated |
KWP | None listed |
| Oct 8, 2010 | Zimmer Inc. SpeedLink 6.0 Transverse Connector X-Long 60-75mm, non-sterile, 1304-60XL Terminated |
KWP | None listed |
| Dec 14, 2009 | Zimmer Inc. Abbott Spine Thoracolumbar Common, SpdLnk 5.5 Trans Cntr Med 43-51 mm, non-sterile, Manufactured by Abbott Spine, Inc., Austin, TX; Ref. 1302-55M. Note: This lot was not distributed in the United St Terminated |
KWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.