510(k) K070241 ยท HRS Plate, Fixation, Bone
MODIFICATION TO LAPIDUS PLATE
| Applicant | New Deal, S.A., Planisboro NJ, US |
| Decision | Substantially Equivalent, Feb 8, 2007 |
| Received | Jan 25, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070241
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 1, 2012 | Integra LifeSciences Corp. Integra Advansys Medial Lisfranc Plate (MLP), Integra, 311 Enterprise Drive, Plainsboro, NJ 08536
The Advansys plates are intended for bone fixation such as: Arthrodesis of the 1st metatarsocuneifor Terminated |
HRS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.