The following data is part of a premarket notification filed by Zimmer Spine, Inc. with the FDA for Minit Posterior Cervical-thoracic Fixation System, Nex-link Spinal Fixation System, Nex-link Oct Cervical Plating System, Sequoia Pedicle Screw System Including Speedlink Ii, St360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System.
| Device ID | K142752 |
| 510k Number | K142752 |
| Device Name: | Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System Including SpeedLink II, ST360º Spinal Fixatoin System, Title 2 Polyaxial Spinal System |
| Classification | Thoracolumbosacral Pedicle Screw System |
| Applicant | ZIMMER SPINE, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 |
| Contact | Donna M. Semlak |
| Correspondent | Donna M. Semlak ZIMMER SPINE, INC. 7375 BUSH LAKE RD. Minneapolis, MN 55439 |
| Product Code | NKB |
| Subsequent Product Code | KWP |
| 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 | 2014-09-24 |
| Decision Date | 2015-06-18 |
| Summary: | summary |