510(k) K071394 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
MODIFICATION TO:SBI RINGFIX
| Applicant | Small Bone Innovations, Inc., New York NY, US |
| Decision | Substantially Equivalent, Jun 29, 2007 |
| Received | May 21, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071394
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 4, 2014 | Small Bone Innovations, Inc. SBi RingFix Olive Wires
Product Usage: These are temporary devices indicated for: osteosynthesis of fractures with small osteoarticular fragments, fixation of open and closed fractures, arthrodesis, Terminated |
KTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.