510(k) K050882 ยท HSB Rod, Fixation, Intramedullary And Accessories
NEWDEAL ANKLE NAIL
| Applicant | New Deal, S.A., Planisboro NJ, US |
| Decision | Substantially Equivalent, May 27, 2005 |
| Received | Apr 7, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050882
| 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 |
| Apr 16, 2012 | Integra LifeSciences Corp. Panta Arthrodesis Nail Support device, 510 (k) #K050882. One (1) unit of product is kitted within an instrumentation tray. The product is available in six (6) sizes. All nails are color-coded for eas Terminated |
HSB | None listed |
| Nov 2, 2010 | Integra LifeSciences Corporation Panta Support Device Panta Arthrodesis Nail Instrumentation Tray One unit per package.
The PANTA(R) Nail is intended for use in tibiotalocalcaneal arthrodesis and treatment of trauma to the hindfoot Terminated |
HSB | None listed |
| Sep 16, 2008 | Integra LifeSciences Corp. PANTA Nails, 10mm x 150 length, Newdeal, Lyon France; Integra, 311 Enterprise Drive, Plainsboro, NJ. The Newdeal Ankle Nail is intended for use in tibiotalocalcaneal arthrodesis and the treatment of Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.