510(k) K051957 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
REPROCESSED EXTERNAL FIXATION DEVICE
| Applicant | Sterilemed, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, Sep 21, 2005 |
| Received | Jul 15, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051957
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 13, 2009 | Sterilmed Inc External Fixation Device
Model #'s:
ORT99-36501
SYN390.005
SYN390.008
SYN394.84
SYN394.85 and
SYN394.86
Intended for use in the construction of an external fixation frame for treatment of a various f Terminated |
KTT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.