Company ยท US
Spinal Concepts, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1997 to 2005. Name variants (Inc, Corp, punctuation) are merged.
33510(k) clearances (0 in 12 months)
8recalls (0 in 12 months)
8recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | 9 |
| KWP | Appliance, Fixation, Spinal Interlaminal | 8 |
| MQP | Spinal Vertebral Body Replacement Device | 6 |
| JDK | Prosthesis, Hip, Cement Restrictor | 5 |
| MNI | Orthosis, Spinal Pedicle Fixation | 5 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | 2 |
| NKB | Thoracolumbosacral Pedicle Screw System | 2 |
| GZT | Retractor, Self-Retaining, For Neurosurgery | 1 |
| HRS | Plate, Fixation, Bone | 1 |
| HWC | Screw, Fixation, Bone | 1 |
| JDQ | Cerclage, Fixation | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 19, 2005 | K051000 | FORTITUDE VUE VERTEBRAL BODY REPLACEMENT DEVICE Spinal Concepts, Inc. | MQP |
| Apr 15, 2005 | K050706 | HARMONY PORT SYSTEM, MODEL 1907 SERIES Spinal Concepts, Inc. | GZT |
| Jul 1, 2004 | K040096 | SPINAL CONCEPTS, INC. TANDEM SPINOUS PROCESS PLATE SYSTEM Spinal Concepts, Inc. | KWP |
| May 27, 2004 | K033663 | SPINAL CONCEPTS INC. CODA Spinal Concepts, Inc. | MQP |
| Feb 18, 2004 | K033517 | SPINAL CONCEPTS INC. CADENCE AND TRAXIS Spinal Concepts, Inc. | MQP |
| Sep 17, 2003 | K031855 | SPINAL CONCEPTS, INC. INSIGHT PEDICLE SCREW SYSTEM Spinal Concepts, Inc. | KWQ |
| Sep 11, 2003 | K031985 | SPINAL CONCEPTS INC. NEX-LINK SPINAL FIXATION SYSTEM Spinal Concepts, Inc. | MNI |
| Aug 22, 2003 | K031318 | TRAXIS CEMENT RESTRICTOR Spinal Concepts, Inc. | JDK |
| Aug 7, 2003 | K031672 | SPINAL CONCEPTS, INC. INFIX SYSTEM Spinal Concepts, Inc. | MQP |
| Jul 24, 2003 | K031837 | MODIFICATION TO FORTITUDE CEMENT RESTRICTOR Spinal Concepts, Inc. | JDK |
| Jul 17, 2003 | K030087 | SPINAL CONCEPTS, INC. BACFIX TI SPINAL SYSTEM Spinal Concepts, Inc. | NKB |
| Jul 12, 2003 | K031914 | SPINAL CONCEPTS, INC. CADENCE AND FORTITUDE Spinal Concepts, Inc. | MQP |
| Mar 28, 2003 | K030625 | SPINAL CONCEPTS INC. PATHFINDER Spinal Concepts, Inc. | NKB |
| Jan 23, 2003 | K024326 | SPINAL CONCEPTS, INC. ANT-CER DYNAMIC ANTERIOR CERVICAL PLATE SYSTEM Spinal Concepts, Inc. | KWQ |
| Nov 27, 2002 | K023647 | CADENCE PEEK CEMEENT RESTRICTOR Spinal Concepts, Inc. | JDK |
| Nov 25, 2002 | K023644 | MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM Spinal Concepts, Inc. | MNI |
| Oct 25, 2002 | K021564 | INCOMPASS SPINAL FIXATION SYSTEM Spinal Concepts, Inc. | KWQ |
| Aug 15, 2002 | K021719 | FORTITUDE CEMENT RESTRICTOR Spinal Concepts, Inc. | JDK |
| Aug 12, 2002 | K022218 | CADENCE CEMENT RESTRICTOR Spinal Concepts, Inc. | JDK |
| Jun 18, 2002 | K021009 | OCTAFIX OCCIPITAL CERVICAL PLATING SYSTEM Spinal Concepts, Inc. | KWP |
| Mar 27, 2002 | K020611 | UNIVERSAL BONE PLATE III SYSTEM (UBP III) Spinal Concepts, Inc. | HRS |
| Feb 13, 2002 | K013979 | SC-ACUFIX THINLINE ANTERIOR CERVICAL PLATE SYSTEM Spinal Concepts, Inc. | KWQ |
| Feb 12, 2002 | K013887 | BACFIX SPINAL FIXATION SYSTEM Spinal Concepts, Inc. | MNH |
| May 25, 2001 | K010563 | END-TO-END AND SIDE-BY-SIDE CONNECTORS Spinal Concepts, Inc. | MNI |
| Jan 24, 2001 | K003351 | PARSFIX CABLE-SCREW SYSTEM Spinal Concepts, Inc. | KWP |
| Oct 6, 2000 | K002082 | SPEEDLINK TRANSVERSE CONNECTOR Spinal Concepts, Inc. | KWP |
| Feb 12, 1999 | K990005 | SPINAL CONCEPTS, INC. (SCI) ANTERIOR CERVICAL PLATE SYSTEM Spinal Concepts, Inc. | KWQ |
| Oct 21, 1998 | K983260 | MODIFICATION TO SPINAL CONCEPTS BACFIX TI SPINAL FIXATION SYSTEM Spinal Concepts, Inc. | MNI |
| Oct 21, 1998 | K983258 | MODIFICATION TO SPINAL CONCEPTS BACFIX SPINAL FIXATION SYSTEM Spinal Concepts, Inc. | MNI |
| Mar 18, 1998 | K973687 | SPINAL CONCEPTS, INC., BACFIX TI SPINAL FIXATION SYSTEM Spinal Concepts, Inc. | MNH |
| Dec 19, 1997 | K974020 | SPINAL CONCEPTS, INC., CFIX CABLE SYSTEM Spinal Concepts, Inc. | JDQ |
| Nov 7, 1997 | K973586 | SPINAL CONCEPTS, INC., UNIVERSAL BONE PLATE SYSTEM II Spinal Concepts, Inc. | HWC |
| Mar 26, 1997 | K964404 | BACFIX SPINAL FIXATION SYSTEM Spinal Concepts, Inc. | KWP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Aug 14, 2004 | Spinal Concepts, Inc Harmony MIS Life Instruments, Lumbar Spacer Systems manufactured by Spinal Concepts, Austin, Texas. Part numbers 2851-1-01, 2851-1-30, 2851-2-01, 2851-2-30, 2851-3-01, 2851-3-30, 2851-4-01, 2851-4-30 Terminated |
MQP | K033517 |
| 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 |
| Jul 20, 2004 | Spinal Concepts, Inc 955-5 BackFix Coldwelder II with straight tip manufactured by Spinal Concepts, Austin, Texas Terminated |
KWP | K983258 |
| Jul 20, 2004 | Spinal Concepts, Inc 955-4 BacFix Coldwelder II with angled tip, manufactured by Spinal Concepts, Austin, Texas Terminated |
KWP | K983260 |
| Jul 20, 2004 | Spinal Concepts, Inc 955-3 BacFix Coldwelder, manufactured by Spinal Concepts, Austin, Texas Terminated |
KWP | K964404 |