The following data is part of a premarket notification filed by Abbott Spine, Inc. with the FDA for Sequoia Spinal System (model 3306), Speedlink Transverse Connector (models 3308, 3309, 3310).
| Device ID | K082032 |
| 510k Number | K082032 |
| Device Name: | SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310) |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | ABBOTT SPINE, INC. 5301 RIATA PARK CT., BLDG. F Austin, TX 78727 |
| Contact | David Padgett |
| Correspondent | David Padgett ABBOTT SPINE, INC. 5301 RIATA PARK CT., BLDG. F Austin, TX 78727 |
| Product Code | NKB |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-17 |
| Decision Date | 2008-10-06 |