Panels › Orthopedic › Product code MQP · Class 2
Spinal Vertebral Body Replacement Device
Regulation 888.3060
3510(k)s in 12 months (279 all time)
0recalls in 12 months (46 all time)
42recalls that name a 510(k)
Top companies in MQP
| Company | 510(k)s | Recalls |
|---|---|---|
| Medtronic Sofamor Danek | 36 | 0 |
| Synthes (USA) Products LLC | 0 | 15 |
| Synthes USA (HQ), Inc. | 0 | 12 |
| Globus Medical, Inc. | 11 | 0 |
| Interpore Cross Intl. | 10 | 0 |
| Spine Wave, Inc. | 10 | 0 |
| Depuyacromed | 8 | 0 |
| Ebi, L.P. | 6 | 2 |
| Implex Corp. | 8 | 0 |
| K2m | 8 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 29, 2003 | K023835 | DEVEX MESH SYSTEM Depuyacromed | MQP |
| Jan 23, 2003 | K022143 | INTERPORE CROSS INTERNATIONAL ANTERIOR FIXATION DEVICE (AFD) Interpore Cross Intl. | MQP |
| Nov 19, 2002 | K023570 | MODIFICATION TO VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek | MQP |
| Aug 30, 2002 | K022563 | HYDROCEL VERTEBRAL BODY REPLACEMENT, MODEL 06-172-00XX1 Implex Corp. | MQP |
| Aug 26, 2002 | K021791 | VERTE-STACK SPINAL SYSTEM Medtronic Sofamor Danek | MQP |
| Jul 17, 2002 | K021967 | HEDROCEL VERTEBRAL BODY REPLACEMENT, MODELS 06-112-00XX2 AND 06-132-10XX2 Implex Corp. | MQP |
| Jul 1, 2002 | K011037 | VERTEBRAL SPACER Synthes (Usa) | MQP |
| May 20, 2002 | K021025 | MODIFICATION TO HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ Implex Corp. | MQP |
| May 16, 2002 | K020887 | EBI AIS SPINE SYSTEM Ebi, L.P. | MQP |
| Apr 16, 2002 | K020152 | SYNTHES VERTEBRAL SPACER TI Synthes (Usa) | MQP |
| Mar 21, 2002 | K020522 | MODIFICATION TO SURGICAL TITANIUM MESH SYSTEM Depuyacromed | MQP |
| Feb 21, 2002 | K020204 | TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODELS 8123, 8124, 8132, 8133, 8156, 8157, 8158, & 8189 Interpore Cross Intl. | MQP |
| Feb 6, 2002 | K020048 | MODIFICATION TO GEO STRUCTURE Interpore Cross Intl. | MQP |
| Jan 28, 2002 | K010378 | HEDROCEL VERTEBRAL BODY REPLACEMENT, MODEL XX-YYY-ZZZZ Implex Corp. | MQP |
| Jan 17, 2002 | K014145 | MODIFICATION TO TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL SYSTEM, MODEL 8130, 8131 Interpore Cross Intl. | MQP |
| Dec 27, 2001 | K011406 | SPINAL MESH SYSTEM Medtronic Sofamor Danek, Inc. | MQP |
| Nov 7, 2001 | K013382 | MODIFICATION TO: STACKABLE CAGE SYSTEM Depuyacromed | MQP |
| Nov 7, 2001 | K010989 | TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL, MODEL 8119, 8120, 8130, 8131 Interpore Cross Intl. | MQP |
| Oct 24, 2001 | K010930 | LIFT VB SPINAL SYSTEM Medtronic Sofamor Danek, Inc. | MQP |
| Oct 16, 2001 | K012254 | VBR Osteotech, Inc. | MQP |
| Aug 3, 2001 | K010530 | GEO STRUCTURE Interpore Cross Intl. | MQP |
| Jul 18, 2001 | K003709 | SURGICAL DYNAMICS MESH CAGE SYSTEM United States Surgical, A Division of Tyco Healthc | MQP |
| May 29, 2001 | K003836 | SYNTHES SYNEX SPACER SYSTEM Synthes | MQP |
| May 8, 2001 | K003043 | SURGICAL TITANIUM MESH SYSTEM Depuyacromed | MQP |
| Apr 23, 2001 | K003275 | SYNTHES SYNMESH SPACER SYSTEM Synthes (Usa) | MQP |
| Jan 4, 2001 | K003155 | VERTEBRAL BODY REPLACEMENT Osteotech, Inc. | MQP |
| Jul 26, 2000 | K001340 | STACKABLE CAGE SYSTEM Depuyacromed | MQP |
| Jul 5, 2000 | K983667 | IONICS LEVANTE INTERVERTEBRAL PILLAR, EXPANDABLE Ionics Medical Corp. | MQP |
| Sep 3, 1999 | K990148 | STACKABLE CAGE SYSTEM Depuy Motech Acromed | MQP |
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