The following data is part of a premarket notification filed by Abbott Spine, Inc. with the FDA for Nex-link Spinal Fixation System Open Polyaxial Screws, Models 2112, 2113, 2118, 2119, 2120. Nex-link Spinal Fixation Sy.
| Device ID | K052566 |
| 510k Number | K052566 |
| Device Name: | NEX-LINK SPINAL FIXATION SYSTEM OPEN POLYAXIAL SCREWS, MODELS 2112, 2113, 2118, 2119, 2120. NEX-LINK SPINAL FIXATION SY |
| Classification | Orthosis, Spinal Pedicle Fixation |
| Applicant | ABBOTT SPINE, INC. 5301 RIATA PARK CT., BLDG. F Austin, TX 78727 |
| Contact | Noah Bartsch |
| Correspondent | Noah Bartsch ABBOTT SPINE, INC. 5301 RIATA PARK CT., BLDG. F Austin, TX 78727 |
| Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-19 |
| Decision Date | 2006-01-06 |
| Summary: | summary |