510(k) K070460 ยท NKB Thoracolumbosacral Pedicle Screw System
ALLEZ SPINE CROSS CONNECTORS
| Applicant | Allez Spine, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Jun 11, 2007 |
| Received | Feb 16, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070460
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2008 | Allez Spine, LLC Allez Spine Cross Connectors; Catalog Number: LG-CC1001Cross Link, Small 30-37mm; LG-CC1002 Cross Link, Medium 37-50mm; LG-CC1003
Cross Link, Lange 50-80mm; lT-T01003 Cross Link Torque Hex Driver, 2.5 Terminated |
NKB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.