Panels › Orthopedic › Product code KWQ · Class 2
Appliance, Fixation, Spinal Intervertebral Body
Regulation 888.3060
11510(k)s in 12 months (668 all time)
1recalls in 12 months (214 all time)
165recalls that name a 510(k)
Top companies in KWQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Spine | 6 | 38 |
| Alphatec Spine, Inc. | 9 | 32 |
| RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) | 0 | 41 |
| Zimmer, Inc. | 1 | 37 |
| Medtronic Sofamor Danek | 29 | 8 |
| Nuvasive, Inc. | 21 | 0 |
| K2m | 20 | 0 |
| Depuy Spine, Inc. | 10 | 8 |
| Blackstone Medical, Inc. | 13 | 3 |
| Globus Medical, Inc. | 15 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 26, 2008 | Blackstone Medical, Inc. Hallmark Anterior Cervical Plate System: Primary Bone Screw, Semi Constrained, REF # 62-3140,14mm; Blackstone Medical, 90 Brookdale Drive, Springfield, MA 01104 (The Hallmark Anterior Cervical Plate Terminated |
KWQ | K050892 |
| Mar 27, 2007 | Medtronic Sofamor Danek USA Inc Colorado 2 Spinal System, Anterior Plate, REF8619500, for export only, manufactured at: Warsaw, Indiana USA, Rx only Terminated |
KWQ | None listed |
| Mar 27, 2007 | Medtronic Sofamor Danek USA Inc Colorado 2 Spinal System, Anterior Plate, REF8639500, for export only, manufactured at: Warsaw, Indiana USA, Rx only Terminated |
KWQ | None listed |
| Apr 19, 2006 | Blackstone Medical Inc. ICON Modular Spinal Fixation System used with the:
ICON Implant Case (containing Pedicle Screws) Item Number 54-1090
ICON Instrument Case 1 Item Number: 54-1091
ICON Instrument Case 2 Item Number: 54 Terminated |
KWQ | K042514 |
| Dec 17, 2005 | Abbott Spine SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix Ant-Cer Anterior Cervical Plating Systems. Terminated |
KWQ | None listed |
| Dec 17, 2005 | Abbott Spine SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix ThinLine Anterior Cervical Plating Systems. Terminated |
KWQ | None listed |
| Dec 17, 2005 | Abbott Spine SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix Corpectomy Anterior Cervical Plating Systems. Terminated |
KWQ | None listed |
| Dec 17, 2005 | Abbott Spine SC-AcuFix Core Instruments Surgical Techniques covering SC-AcuFix SlimLine and SlimLine Hybrid Anterior Cervical Plating Systems. Terminated |
KWQ | None listed |
| 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 | K013979 K024326 +1 |
| 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 | K013979 |
| Oct 23, 2004 | Zimmer Spine, Inc. ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays. 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 | K024326 |
| 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 | K024326 |
| 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 | K024326 |
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