510(k) K990005 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM
| Applicant | Spinal Concepts, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Feb 12, 1999 |
| Received | Jan 4, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K990005
| 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.