Trabecular Metal (TM) Vertebral Body Replacement (VBR) System Instrument Set
FDA 510(k) K093127 · Zimmer Trabecular Metal Technology
510(k) numberK093127
Submission
- Device name
- Trabecular Metal (TM) Vertebral Body Replacement (VBR) System Instrument Set
- Applicant
- Zimmer Trabecular Metal Technology
Parsippany, NJ, US - Received
- October 2, 2009
- Decision date
- March 4, 2010
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MQP – Spinal Vertebral Body Replacement Device
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
Other 510(k)s with product code MQP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261810 | Vertiwedge® Intraosseous SystemMQP · Special | Foundation Surgical Group | 07/31/2026SE |
| K261031 | Poseidon STMQP · Traditional | Signus Medinzintechnik GmbH | 07/10/2026SE |
| K253158 | VyBrate VBR SystemMQP · Traditional | Vy Spine, LLC | 01/07/2026SE |
| K241468 | Vertiwedge® Intraosseous SystemMQP · Traditional | Foundation Surgical Group, Inc. | 11/07/2024SE |
| K232790 | KONG®-TL VBR System and KONG® C VBR SystemMQP · Traditional | Icotec AG | 04/04/2024SE |
| K233359 | DOMINION Expandable Corpectomy SystemMQP · Traditional | Astura Medical | 03/08/2024SE |
| K231134 | VerteLoc Spinal SystemMQP · Traditional | Signature Orthopaedics Pty, Ltd. | 02/13/2024SE |
| K232173 | Ascend VBR System, Ascend NanoTec VBR SystemMQP · Traditional | Alphatec Spine, Inc. | 10/06/2023SE |
| K211892 | ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages)MQP · Traditional | Arftx Medical, LLC | 10/06/2022SE |
| K202637 | F3D Corpectomy SystemMQP · Traditional | Corelink, LLC | 12/23/2020SE |
More from Corelink, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K133784 | Vista-S Device, Associated InstrumentationODP · Traditional | 07/07/2014SE |
| K123602 | TM Ardis Interbody System InserterMAX · Traditional | 03/01/2013SE |
| K120990 | Nexgen LCCK Trabecular Metal (TM) Coupled Tibial Cones Provisionals to Nexgen LCCK…MBH · Traditional | 06/29/2012SE |
| K120203 | TM-400 DeviceMAX · Traditional | 06/15/2012SE |
| K113561 | TM Ardis Interbody System TM Ardis Interbody System InstrumenationMAX · Traditional | 05/29/2012SE |
| K111983 | Vista-S Device Model 08/06-401-XXXXX, 08/06-402-XXXXXXODP · Traditional | 11/18/2011SE |
| K103517 | Trabecular Metal Femoral Cone AugmentsMBH · Traditional | 02/15/2011SE |
| K103033 | Trabecular Metal Fusion Device Model 06-101-XXXXX, 06-102-XXXXX and 08-100-XXXXXODP · Traditional | 01/10/2011SE |
| K102896 | Trabecular Metal Tibial Cone AugmentsMBH · Traditional | 12/13/2010SE |
| K070754 | Trabecular Metal Vertebral Body Replacement (VBR), Model# 06-115, 06-155MQP · Traditional | 08/31/2007SE |
Questions and answers
When was Trabecular Metal (TM) Vertebral Body Replacement (VBR) System Instrument Set cleared by the FDA?
Trabecular Metal (TM) Vertebral Body Replacement (VBR) System Instrument Set (K093127) received a 510(k) decision of Substantially Equivalent on March 4, 2010, 153 days after the submission was received.
What is the product code of K093127?
The FDA product code is MQP – Spinal Vertebral Body Replacement Device, a Class II (moderate risk) device regulated under 21 CFR 888.3060.