510(k) K153152 ยท NKB Thoracolumbosacral Pedicle Screw System
Syzygy Stabilization System
| Applicant | Amendia, Inc., Marietta GA, US |
| Decision | Substantially Equivalent, Apr 27, 2016 |
| Received | Nov 2, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153152
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2017 | Amendia, Inc Mac Pin Non-Cannulated Screw, 6.5 x 60mm Terminated |
NKB | None listed |
| Nov 22, 2016 | Amendia, Inc Savannah-T Straight Rod, 200mm, Part Number 10704-200; Savannah-T Straight Rod, 250mm, Part Number 10704-250; Savannah T-Straight Rod 300mm, Part Number 10704-300; Savannah-T Straight Rod, 400mm, Part Terminated |
MNH | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.