510(k) K112794 ยท HRS Plate, Fixation, Bone
EOS SMALL BONE FIXATION SYSTEM
| Applicant | TriMed, Inc., Santa Clarita CA, US |
| Decision | Substantially Equivalent, May 10, 2012 |
| Received | Sep 26, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112794
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 13, 2018 | TriMed Inc. Nitinol Staple, Elastic Staple Large-Asymmetrical, Sterile R, Model #: a) ES-18x15x17; b) ES-18x17x19 Terminated |
JDR | None listed |
| Apr 13, 2018 | TriMed Inc. Nitinol Staple, Elastic Staple Large-Symmetrical, Sterile R, Model #: a) ES-18x14; b) ES-20x20; c) ES-25x22 Terminated |
JDR | None listed |
| Apr 13, 2018 | TriMed Inc. Nitinol Staple, Elastic Staple Small-Asymmetrical, Sterile R, Model #: a) ES-10x13x15; b) ES-10x16x19; c) ES-10x17x19; d) ES-12x13x15; e) ES-12x15x17; f) ES-12x16x19; g) ES-15x13x16 Terminated |
JDR | None listed |
| Apr 13, 2018 | TriMed Inc. Nitinol Staple, Elastic Staple Small-Symmetrical, Sterile R, Model #: a) ES-08x08; b) ES-10x10; c) ES-10x13; d) ES-12x10; e) ES-15x12; f) ES-10x14; g) ES-10x15 Terminated |
JDR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.