510(k) K101993 ยท NKB Thoracolumbosacral Pedicle Screw System
VIPER SYSTEM, EXPEDIUM SYSTEM
| Applicant | Depuy Spine, Inc., Raynham MA, US |
| Decision | Substantially Equivalent, Dec 7, 2010 |
| Received | Jul 15, 2010 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K101993
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 24, 2013 | DePuy Spine, Inc. DePuy Spine VIPER POLY SCREW 5.5 8 X70MM Tl
Product Code: 1867-15-870
Spinal Implant Component. Terminated |
NKB | None listed |
| Jan 24, 2013 | DePuy Spine, Inc. DePuy Spine VIPER POLY SCREW 5.5 8 X80MM Tl
Product Code: 1867-15-880
Spinal Implant Component. Terminated |
NKB | None listed |
| Jan 24, 2013 | DePuy Spine, Inc. DePuy Spine VIPER POLY SCREW 5.5 8 X100MM Tl
Product Code: 1867-15-899
Spinal Implant Component. Terminated |
NKB | None listed |
| Jan 24, 2013 | DePuy Spine, Inc. DePuy Spine VIPER POLY SCREW 5.5 9 X70MM Tl
Product Code: 1867-15-970
Spinal Implant Component. Terminated |
NKB | None listed |
| Jan 24, 2013 | DePuy Spine, Inc. DePuy Spine VIPER POLY SCREW 5.5 9 X 80MM Tl
Product Code: 1867-15-980
Spinal Implant Component. Terminated |
NKB | None listed |
| Jan 24, 2013 | DePuy Spine, Inc. DePuy Spine VIPER POLY SCREW 5.5 9 X100MM Tl
Product Code: 1867-15-999
Spinal Implant Component. Terminated |
NKB | None listed |
| Jan 24, 2013 | DePuy Spine, Inc. DePuy Spine VIPER POLY SCREW 5.5 10 X 80MM Tl
Product Code: 1867-15-180
Spinal Implant Component. Terminated |
NKB | None listed |
| Jan 24, 2013 | DePuy Spine, Inc. DePuy Spine VIPER POLY SCREW 5.5 10X100MM Tl
Product Code: 1867-15-199
Spinal Implant Component. Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.