Pathway Model 07XXXX
FDA 510(k) K111774 · Custom Spine
510(k) numberK111774
Submission
- Device name
- Pathway Model 07XXXX
- Applicant
- Custom Spine
Parsippany, NJ, US - Received
- June 23, 2011
- Decision date
- July 20, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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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 |
| 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 |
| K090566 | Pathway AvidMAX · Traditional | 06/01/2009SE |
| K080281 | PathwayMAX · Traditional | 05/01/2008SE |
Questions and answers
When was Pathway Model 07XXXX cleared by the FDA?
Pathway Model 07XXXX (K111774) received a 510(k) decision of Substantially Equivalent on July 20, 2011, 27 days after the submission was received.
What is the product code of K111774?
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.