Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE)
FDA 510(k) K143297 · Zimmer Spine, Inc.
510(k) numberK143297
Submission
- Device name
- Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE)
- Applicant
- Zimmer Spine, Inc.
Minneapolis, MN, US - Received
- November 17, 2014
- Decision date
- February 12, 2015
- 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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| K261049 | Scala® TLMAX · Traditional | Spineart SA | 08/20/2026SE |
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| K253151 | Fule Interbody Fusion Cage SystemMAX · Traditional | Beijing Fule Science & Technology Development… | 06/15/2026SE |
| K261159 | Exceed® Biplanar Expandable Interbody SystemMAX · Traditional | Spine Wave, Inc. | 05/29/2026SE |
| K253894 | BMD Titanium Spinal Fusion SystemMAX · Traditional | Global Biomedica s.r.o. | 05/28/2026SE |
| K260506 | Ventana® P/T Lumbar Interbody SystemMAX · Traditional | Spinal Elements, Inc. | 05/15/2026SE |
| K260837 | VersaLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 05/12/2026SE |
More from Life Spine, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K153631 | Zimmer Virage OCT Spinal Fixation SystemNKG · Special | 02/16/2016SE |
| K150896 | Vitality Spinal Fixation SystemNKB · Traditional | 08/31/2015SE |
| K151031 | Virage OCT Spinal Fixation SystemNKG · Traditional | 06/24/2015SE |
| K142752 | Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System…NKB · Traditional | 06/18/2015SE |
| K143626 | inVizia Anterior Certical Plate System, SC-AcuFix Ant-Cer Dynamic Cervical Plating…KWQ · Traditional | 03/20/2015SE |
| K142053 | Universal Clamp Spinal Fixation SystemOWI · Traditional | 10/29/2014SE |
| K141500 | Optio-C Anterior Cervical SystemKWQ · Traditional | 09/23/2014SE |
| K133556 | Virage Oct Spinal Fixation SystemKWP · Traditional | 06/02/2014SE |
| K140611 | Trinica Anterior Lumbar Plate SystemKWQ · Traditional | 05/21/2014SE |
| K133184 | Ardis Interbody SystemMAX · Traditional | 01/30/2014SE |
Questions and answers
When was Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE) cleared by the FDA?
Ardis Interbody System, BAK Interbody Fusion System, BAK/C Anterior Cervical Interbody Fusion System, InFix Anterior Lumbar System, TraXis Vertebral Body Replacement (Ti and VUE) (K143297) received a 510(k) decision of Substantially Equivalent on February 12, 2015, 87 days after the submission was received.
What is the product code of K143297?
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.