The following data is part of a premarket notification filed by Zimmer Spine, Inc with the FDA for Pathfinder Ii, Minimally Invasie Pedicle Screw System Model 3500 Series.
| Device ID | K100845 |
| 510k Number | K100845 |
| Device Name: | PATHFINDER II, MINIMALLY INVASIE PEDICLE SCREW SYSTEM MODEL 3500 SERIES |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | ZIMMER SPINE, INC 5301 RIATA PARK COURT BUILDING F Austin, TX 78727 |
| Contact | David Padgett, Rac (us) |
| Correspondent | David Padgett, Rac (us) ZIMMER SPINE, INC 5301 RIATA PARK COURT BUILDING F Austin, TX 78727 |
| Product Code | NKB |
| Subsequent Product Code | MNH |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-25 |
| Decision Date | 2010-09-21 |
| Summary: | summary |