510(k) K163293 · HRS Plate, Fixation, Bone
Colink Plating System
| Applicant | In2bones USA, LLC, Memphis TN, US |
| Decision | Substantially Equivalent, May 5, 2017 |
| Received | Nov 22, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K163293
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 16, 2018 | In2bones USA, LLC CoLink(TM) Lapidus Plate XP, +2 mm, Right, REF P40 ST165, QTY 1, In2Bones
Product Usage:
The In2Bones USA LLC, CoLink Plating System is indicated for stabilization and fixation of fractures, revisio Terminated |
HWC | None listed |
| Jul 16, 2018 | In2bones USA, LLC CoLink(TM) Lapidus Plate XP, +2 mm, Left, REF P40 ST265, QTY 1, In2Bones
Product Usage:
The In2Bones USA LLC, CoLink Plating System is indicated for stabilization and fixation of fractures, revision Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.