510(k) K132912 ยท HWC Screw, Fixation, Bone
DUAFIT INTERGPHALANGEAL IMPLANT, PEEK-FUSE INTERPHALANGEAL IMPLANT
| Applicant | In2bones Sas, Potomac MD, US |
| Decision | Substantially Equivalent, Jul 30, 2014 |
| Received | Sep 17, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K132912
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 25, 2015 | In2Bones, SAS DUAFIT(R) PIP 0o CA SIZE 2, REF A60 SP002, STERILE R, Rx only.
Interphalangeal implant. Terminated |
HWC | None listed |
| Mar 25, 2015 | In2Bones, SAS DUAFIT(R) PIP 0o CA SIZE 3, REF A60 SP003, STERILE R, Rx only.
Interphalangeal implant. Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.