Pathway Avid
FDA 510(k) K090566 · Custom Spine, Inc.
510(k) numberK090566
Submission
- Device name
- Pathway Avid
- Applicant
- Custom Spine, Inc.
Parsippany, NJ, US - Received
- March 3, 2009
- Decision date
- June 1, 2009
- 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 |
| K261430 | TruLift Expandable SystemMAX · Traditional | Life Spine, Inc. | 07/28/2026SE |
| K253011 | Catalyft PL Expandable Interbody SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/17/2026SE |
| K261020 | Symmetrix L Spinal SystemMAX · Traditional | Medtronic Sofamor Danek USA, Inc. | 07/14/2026SE |
| K253420 | Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer…MAX · Traditional | SeaSpine Orthopedics Corporation | 07/01/2026SE |
| 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 |
|---|---|---|
| K143143 | Pathway ElifMAX · Traditional | 07/22/2015SE |
| K132596 | Proposed OptimusOVD · Traditional | 04/11/2014SE |
| K120597 | KompredaMRW · Traditional | 05/03/2013SE |
| K111726 | Pathway AvidMAX · Traditional | 02/06/2012SE |
| K111774 | Pathway Model 07XXXXMAX · Special | 07/20/2011SE |
| K111099 | Issys LP Spinal Fixation SystemNKB · Special | 05/05/2011SE |
| K101151 | Regent Anterior Cervical PlateKWQ · Special | 05/19/2010SE |
| K092904 | Pathway Ivb/VbrODP · Traditional | 12/22/2009SE |
| K091134 | Custom Spine Regent Anterior Cervical PlateKWQ · Traditional | 08/17/2009SE |
| K080281 | PathwayMAX · Traditional | 05/01/2008SE |
Questions and answers
When was Pathway Avid cleared by the FDA?
Pathway Avid (K090566) received a 510(k) decision of Substantially Equivalent on June 1, 2009, 90 days after the submission was received.
What is the product code of K090566?
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.