510(k) K051410 ยท HRS Plate, Fixation, Bone
ACUMED RIB CONGRIENT BONE PLATE SYSTEM
| Applicant | Acumed, LLC, Hillsboro OR, US |
| Decision | Substantially Equivalent, Jul 21, 2005 |
| Received | May 31, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051410
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 1, 2011 | Acute Innovations Llc 10mm x 2.7mm RibLoc Screw, a component of the RibLoc Rib Fracture Plating System, Model RBP1202.
The product is labeled in parts: "***Ribloc Rib Fracture Plating System***MATERIAL: Titanium***Rx ONLY Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.