510(k) K013979 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEM
| Applicant | Spinal Concepts, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Feb 13, 2002 |
| Received | Dec 3, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K013979
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 17, 2005 | Abbott Spine SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix SlimLine, SlimLine Hybrid, Corpectomy, ThinLine and Ant-Cer Anterior Cervical Plating Systems. Terminated |
KWQ | None listed |
| Jun 11, 2005 | Spinal Concepts, Inc SC-AcuFix Thinline Low-Profile Anterior Cervical Plate System manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company, Austin, Texas Terminated |
KWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.