510(k) K051942 ยท KWP Appliance, Fixation, Spinal Interlaminal
MALIBU SPINAL SYSTEM
| Applicant | Seaspine, Inc., Vista CA, US |
| Decision | Substantially Equivalent, Jul 27, 2005 |
| Received | Jul 15, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051942
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 7, 2014 | Integra LifeSciences Corp. Malibu Polyaxial Screwdriver, 8.0 Plus, Model Number 91-2109;
Malibu Polyaxial Screwdriver, Standard, Model Number 91-2110.
510(k):
91-2109 K061342.
91-2110 K051942.
The Malibu" System is int Terminated |
NKB | None listed |
| Sep 3, 2009 | SeaSpine, Inc Malibu Polyaxial Screw, 4.5 x 30mm Part Number 12-4530
Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization Terminated |
KWP | None listed |
| Sep 3, 2009 | SeaSpine, Inc Malibu Polyaxial Screw, 6.5 x 35mm Part Number 12-6535
Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization Terminated |
KWP | None listed |
| Sep 3, 2009 | SeaSpine, Inc Malibu Polyaxial Screw, 6.5 x 40mm Part Number 12-6540
Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization Terminated |
KWP | None listed |
| Sep 3, 2009 | SeaSpine, Inc Malibu Polyaxial Screw, 6.5 x 45mm Part Number 12-6545
Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization Terminated |
KWP | None listed |
| Sep 3, 2009 | SeaSpine, Inc Malibu Polyaxial Screw, 6.5 x 50mm Part Number 12-6550
Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization Terminated |
KWP | None listed |
| Sep 3, 2009 | SeaSpine, Inc Malibu Polyaxial Screw, 7.5 x 35mm Part Number 12-7535
Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization Terminated |
KWP | None listed |
| Sep 3, 2009 | SeaSpine, Inc Malibu Polyaxial Screw, 7.5 x 70mm Part Number 12-7570
Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immobilization Terminated |
KWP | None listed |
| Sep 3, 2009 | SeaSpine, Inc Malibu Polyaxial Reduction Screw, 6.5 x 40mm Part Number 13-6540
Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immob Terminated |
KWP | None listed |
| Sep 3, 2009 | SeaSpine, Inc Malibu Polyaxial Reduction Screw, 6.5 x 45mm Part Number 13-6545
Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immob Terminated |
KWP | None listed |
| Sep 3, 2009 | SeaSpine, Inc Malibu Polyaxial Reduction Screw, 6.5 x 50mm Part Number 13-6550
Malibu Spinal System when used as a Pedicle Screw Spinal System or Spondylolisthesis Spinal Fixation Device System is to provide immob Terminated |
KWP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.