The following data is part of a premarket notification filed by Abbott Spine, Inc. with the FDA for Pathfinder System Polyaxial Pedicle Screws.
| Device ID | K071174 |
| 510k Number | K071174 |
| Device Name: | PATHFINDER SYSTEM POLYAXIAL PEDICLE SCREWS |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | ABBOTT SPINE, INC. 5301 RIATA PARK CT., BLDG. F Austin, TX 78727 |
| Contact | Zara Oakes |
| Correspondent | Zara Oakes ABBOTT SPINE, INC. 5301 RIATA PARK CT., BLDG. 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-27 |
| Decision Date | 2007-07-25 |
| Summary: | summary |