510(k) K942340 ยท HWC Screw, Fixation, Bone
CORTICAL BONE SCREW
| Applicant | Acu Med, Inc., Beaverton OR, US |
| Decision | Substantially Equivalent for Some Indications, Dec 5, 1994 |
| Received | May 16, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K942340
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 14, 2010 | Acumed LLC Polarus(R) Humeral Fixation System, size: 3.5mm x 25.0mm Cortical Screw, QTY 1, Ref: HCO3250-S Acumed, LLC Hillsboro, OR
Intended use: Acumed intramedullary rods and screws are designed to provide Terminated |
HWC | None listed |
| Sep 11, 2008 | Acumed LLC Smooth or threaded metallic bone fixation fastener. 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in 3.5mm x 14.0 mm Locking Cortical Screw. Product labeled in part, "Congruent Plate System Terminated |
HWC | None listed |
| Aug 28, 2008 | Acumed LLC 3.5mm X 32.5mm Cortical Screw used with the Polarus Humeral Fixation System,. Product labeled in part, "Polarus Humeral Fixation System& SIZE: 3.5mm X 32.5mm Cortical Screw... REF HCO3325-S... Acumed Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.