510(k) K140463 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
INTEGRA EXTERNAL FIXATION SYSTEM
| Applicant | Ascension Orthopedic, Providence UT, US |
| Decision | Substantially Equivalent, Oct 10, 2014 |
| Received | Feb 24, 2014 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K140463
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2016 | Integra LifeSciences Corp. Integra External Fixation System Universal Wire Fixation Bolt - 17.5 mm Catalogue #12224218 ; Integra External Fixation System Universal Wire Fixation Bolt - 23 mm Catalogue #12224219 Terminated |
KTT | None listed |
| Jul 20, 2016 | Integra LifeSciences Corp. Integra External Fixation System Slotted Post - Small Catalogue #12224228; Integra External Fixation System Slotted Post Large Catalogue #12224229 Terminated |
KTT | None listed |
| Jul 1, 2016 | Integra LifeSciences Corp. Integra External Fixation System Rocker Bottom Model # 12225400.
For use in the treatment of bone conditions amenable to treatment by the use of external fixation. Terminated |
KTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.