510(k) K052552 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
HYBRID ANTERIOR CERVICAL PLATE SYSTEM
| Applicant | Depuy Spine, Inc., Raynham MA, US |
| Decision | Substantially Equivalent, Oct 13, 2005 |
| Received | Sep 16, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K052552
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 12, 2016 | DePuy Spine, Inc. DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm
Item Code: 186850018
The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to Terminated |
KWQ | None listed |
| Oct 12, 2016 | DePuy Spine, Inc. DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-DRILLING SCREW 4.0 x 18mm
Item Code: 186852018
The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to Terminated |
KWQ | None listed |
| Oct 12, 2016 | DePuy Spine, Inc. DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 20mm
Item Code: 186852020
The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to C7 Terminated |
KWQ | None listed |
| Oct 12, 2016 | DePuy Spine, Inc. DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE SELF-TAPPING SCREW 4.0 x 26mm
Item Code: 186852026
The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to C7 Terminated |
KWQ | None listed |
| Oct 12, 2016 | DePuy Spine, Inc. DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM VARIABLE OVERSIZED SCREW 4.5 x 18mm
Item Code: 186854018
The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to C7 fo Terminated |
KWQ | None listed |
| Oct 12, 2016 | DePuy Spine, Inc. DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED SELF-TAPPING SCREW 4 x 18mm
Item Code: 186862018
The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to Terminated |
KWQ | None listed |
| Oct 12, 2016 | DePuy Spine, Inc. DePuy Spine SKYLINE ANTERIOR CERVICAL PLATE SYSTEM CONSTRAINED OVERSIZED SCREW 4.5 x 18mm
Item Code: 186864018
The SKYLINE Anterior Cervical Plate System is indicated for stabilization from C2 to C Terminated |
KWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.