510(k) K024326 ยท KWQ Appliance, Fixation, Spinal Intervertebral Body
SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM
| Applicant | Spinal Concepts, Inc., Austin TX, US |
| Decision | Substantially Equivalent, Jan 23, 2003 |
| Received | Dec 26, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K024326
| 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 |
| Jul 20, 2004 | Spinal Concepts, Inc One-level Ant-Cer Plates (Assembly Level). 1706-1024, 1706-1026, 1706-1028, 1706-1030, 1706-1032, and product literature. Devices are manufactured by Spinal Concepts, Inc., An Abbott Laboratories Com Terminated |
KWQ | None listed |
| Jul 20, 2004 | Spinal Concepts, Inc 1757-1: Compressor/Distractor Instrument (aka Plate Distractor Forceps), and product literature. Devices are manufactured by Spinal Concepts, Inc., An Abbott Laboratories Company Terminated |
KWQ | None listed |
| Jul 20, 2004 | Spinal Concepts, Inc Ant-Cer Dynamic Cervical Plating System Literature. Device is manufactured by Spinal Concepts, Austin, TX Terminated |
KWQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.