510(k) K070447 ยท HRS Plate, Fixation, Bone
NEWDEAL COMPRESSION PLATE
| Applicant | Newdeal Sas, Planisboro NJ, US |
| Decision | Substantially Equivalent, Mar 29, 2007 |
| Received | Feb 15, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K070447
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 25, 2011 | Integra LifeSciences Corp. Newdeal (Newdeal Compression Plate) Model #UNI-CP 339900 Sets, Lot Numbers: E71H, E7V1, E86R, EELE, EGTC
The Newdeal Compression Plates are intended for fixation of bone fractures or for bone reconst Terminated |
HRS | None listed |
| Dec 1, 2008 | Integra LifeSciences Corp Uni-CP Compression Forceps (spreader);
Non-sterile, R only, Catalog number: 339001ND
Newdeal, Lyon, France;
Integra, 411 Enterprise Drive, Plainsboro, NJ 08536
Intended to open the UNI-Compression P Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.