510(k) K151256 · PLF Bone Wedge
Arthrex BioSync® Bone Wedge
| Applicant | Arthex, Inc., Naples FL, US |
| Decision | Substantially Equivalent, Aug 12, 2015 |
| Received | May 12, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K151256
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 22, 2016 | Arthrex, Inc. BioSync Anatomic Cotton Wedge, 16 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot. Terminated |
PLF | None listed |
| Apr 22, 2016 | Arthrex, Inc. BioSync Anatomic Cotton Wedge, 16 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot. Terminated |
PLF | None listed |
| Apr 22, 2016 | Arthrex, Inc. BioSync Anatomic Cotton Wedge, 16 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot. Terminated |
PLF | None listed |
| Apr 22, 2016 | Arthrex, Inc. BioSync Anatomic Cotton Wedge, 20 x 4.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot. Terminated |
PLF | None listed |
| Apr 22, 2016 | Arthrex, Inc. BioSync Anatomic Cotton Wedge, 20 x 5.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot. Terminated |
PLF | None listed |
| Apr 22, 2016 | Arthrex, Inc. BioSync Anatomic Cotton Wedge, 20 x 6.5 mm.; Used for internal bone fixation for bone fractures, fusions or osteotomies in the ankle and foot. Terminated |
PLF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.