Interbody Cage
FDA 510(k) K140348 · Eisertech, LLC
510(k) numberK140348
Submission
- Device name
- Interbody Cage
- Applicant
- Eisertech, LLC
San Diego, CA, US - Received
- February 11, 2014
- Decision date
- April 23, 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.
Other 510(k)s with product code MAX
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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 |
|---|---|---|
| K192768 | Temporary Fixation PinsJDW · Traditional | 12/26/2019SE |
| K190565 | Cervical PlateKWQ · Traditional | 05/31/2019SE |
| K142576 | Spinal SystemNKB · Traditional | 02/26/2015SE |
| K122444 | Cervical CageODP · Special | 08/30/2012SE |
| K113170 | Cervical PlateKWQ · Traditional | 04/06/2012SE |
| K113478 | Plif CageMAX · Abbreviated | 03/05/2012SE |
| K110915 | Cervical CageODP · Abbreviated | 07/22/2011SE |
Questions and answers
When was Interbody Cage cleared by the FDA?
Interbody Cage (K140348) received a 510(k) decision of Substantially Equivalent on April 23, 2015, 436 days after the submission was received.
What is the product code of K140348?
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.