510(k) K173767 ยท HRS Plate, Fixation, Bone
A. L. P. S. Clavicle Plating System
| Applicant | Biomet, Inc., Warsaw IN, US |
| Decision | Substantially Equivalent, Apr 6, 2018 |
| Received | Dec 11, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K173767
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 21, 2021 | Biomet, Inc. A.L.P.S. Clavicle Plating System, Plate, Fixation, Bone, Item Number 233500004 - Product Usage: indicated for fixation of fractures, osteotomies and non-unions of the clavicle including osteopenic bon Terminated |
HRS | None listed |
| May 14, 2020 | Biomet A.L.P.S. T15 LOW PROFILE CORTICAL SCREW
3.5mm x 28mm, Item Number: 110017628 - Product Usage: Intended for temporary internal fixation and stabilization of osteotomies and fractures during the normal Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.