The following data is part of a premarket notification filed by Abbott Spine, Inc. with the FDA for The Sc-acufix Ant-cer Dynamic Cervical Plate System Single Level Plates.
| Device ID | K052072 |
| 510k Number | K052072 |
| Device Name: | THE SC-ACUFIX ANT-CER DYNAMIC CERVICAL PLATE SYSTEM SINGLE LEVEL PLATES |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| 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 | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-08-01 |
| Decision Date | 2005-08-29 |
| Summary: | summary |