510(k) K091788 ยท HSB Rod, Fixation, Intramedullary And Accessories
PANTA NAIL (DIA. 10MM), PANTA NAIL XL
| Applicant | Newdeal Sas, Planisboro NJ, US |
| Decision | Substantially Equivalent, Jul 29, 2009 |
| Received | Jun 17, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K091788
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 3, 2017 | Integra LifeSciences Corp. Panta Nail, Rx only, Sterile, Terminated |
HSB | None listed |
| Jul 16, 2013 | Integra LifeSciences Corporation Integra PANTA Arthrodesis Nail System.
Intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot and distal tibia. Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.