510(k) K113561 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
TM ARDIS INTERBODY SYSTEM TM ARDIS INTERBODY SYSTEM INSTRUMENATION
| Applicant | Zimmer Trabecular Metal Technology, Parsippany NJ, US |
| Decision | Substantially Equivalent, May 29, 2012 |
| Received | Dec 1, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K113561
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 7, 2016 | Zimmer Trabecular Metal Technology, Inc. The TM Ardis Interbody System implant is a convex, straight TLIF or PLIF device for interbody fusion of the anterior column of the spine. TM Ardis is designed for fusing the adjacent bony surfaces and Terminated |
MAX | None listed |
| Jan 9, 2013 | Zimmer, Inc. The TM Ardis Interbody System Inserter Stainless Steel, Rubber, Silicone Non Sterile Rx only.
The TM Ardis Inserter is intended for delivery of the TM Ardis Implant into the cleared disc space. The i Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.