510(k) K100845 ยท NKB Thoracolumbosacral Pedicle Screw System
PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES
| Applicant | Zimmer Spine, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Sep 21, 2010 |
| Received | Mar 25, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K100845
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2012 | Zimmer, Inc. Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-1 (angle handle) , Stainless Steel / Silicone Rubber, Rx only, non sterile.
Product Usage:
The rod is held by the instrument for insert Terminated |
NKB | None listed |
| Jul 10, 2012 | Zimmer, Inc. Pathfinder NXT Fixed Percutaneous Rod Holder, Part numbers 3573-2 (straight handle) Stainless Steel / Silicone Rubber, Rx only, non sterile.
Product Usage:
PathFinder NXT is a minimally invasive pedi Terminated |
NKB | None listed |
| Jul 3, 2012 | Zimmer, Inc. PathFinder NXT Pivoting Percutaneous Rod Holder
This device is an instrument used during orthopedic surgery. The intended use of the pivoting percutaneous rod holder is to attach to the rod to facili Terminated |
NKB | None listed |
| Jul 6, 2011 | Zimmer Inc. Pathfinder NXT Closure top driver - long, REF 3566-1, Zimmer Inc., Warsaw, IN
Product Usage: The Closure Top Driver is used in conjunction with compressors, distractors, and reducers, as needed, to Terminated |
HXX | None listed |
| Jul 6, 2011 | Zimmer Inc. Pathfinder NXT Closure top driver - short, REF 3566-2, Zimmer Inc., Warsaw, IN
Product Usage: The Closure Top Driver is used in conjunction with compressors, distractors, and reducers, as needed, to Terminated |
HXX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.