510(k) K111099 ยท NKB Thoracolumbosacral Pedicle Screw System
ISSYS LP SPINAL FIXATION SYSTEM
| Applicant | Custom Spine, Inc., Parsippany NJ, US |
| Decision | Substantially Equivalent, May 5, 2011 |
| Received | Apr 20, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K111099
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 29, 2013 | Custom Spine, Inc. Custom Spine ISSYS LP Inverted Screw System. 8.5MM X 45 MM ISSYS LP Screw Rx Non-Sterile. Custom Spine, Inc. 9 Campus Dr. Parsippany, NJ 07054 USA. TEL: 973-808-0019
The ISSYS LP Spinal Fixation Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.