510(k) K083154 ยท HRS Plate, Fixation, Bone
NEWDEAL HALLU LOCK PLATE SYSTEM
| Applicant | Newdeal Sas, Planisboro NJ, US |
| Decision | Substantially Equivalent, Jul 10, 2009 |
| Received | Oct 24, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K083154
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 2, 2012 | Integra LifeSciences Corp. Titanium SURFIX ALPHA SCREWS, a component of the Newdeal Hallu Lock Plate System. Surfix Alpha Variable angle locking system exists in different diameters and lengths. The product can be sold as a re Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.