TM Ardis Interbody System TM Ardis Interbody System Instrumenation
FDA 510(k) K113561 · Zimmer Trabecular Metal Technology
510(k) numberK113561
Submission
- Device name
- TM Ardis Interbody System TM Ardis Interbody System Instrumenation
- Applicant
- Zimmer Trabecular Metal Technology
Parsippany, NJ, US - Received
- December 1, 2011
- Decision date
- May 29, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MAX – Intervertebral Fusion Device With Bone Graft, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
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| 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 |
| 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 |
| K093127 | Trabecular Metal (TM) Vertebral Body Replacement (VBR) System Instrument SetMQP · Traditional | 03/04/2010SE |
| K070754 | Trabecular Metal Vertebral Body Replacement (VBR), Model# 06-115, 06-155MQP · Traditional | 08/31/2007SE |
Questions and answers
When was TM Ardis Interbody System TM Ardis Interbody System Instrumenation cleared by the FDA?
TM Ardis Interbody System TM Ardis Interbody System Instrumenation (K113561) received a 510(k) decision of Substantially Equivalent on May 29, 2012, 180 days after the submission was received.
What is the product code of K113561?
The FDA product code is MAX – Intervertebral Fusion Device With Bone Graft, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.