Amendia Interbody Fusion Devices
FDA 510(k) K160924 · Amendia, Inc.
510(k) numberK160924
Submission
- Device name
- Amendia Interbody Fusion Devices
- Applicant
- Amendia, Inc.
Marietta, GA, US - Received
- April 4, 2016
- Decision date
- November 8, 2016
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K161842 | Overwatch Spine SystemNKB · Traditional | 10/13/2016SE |
| K152920 | Savannah-T® Pedicle Screw SystemNKB · Traditional | 07/08/2016SE |
| K153152 | Syzygy Stabilization SystemNKB · Traditional | 04/27/2016SE |
| K160291 | Optimus ALIF SystemOVD · Special | 02/18/2016SE |
| K152972 | Amendia Stand-Alone Cervical SystemOVE · Traditional | 01/14/2016SE |
| K151310 | Amendia Interbody Fusion DevicesMAX · Traditional | 01/06/2016SE |
| K152460 | Rectangular Corpectomy CageMQP · Traditional | 12/22/2015SE |
| K152455 | Amendia Cervical Plate SystemKWQ · Traditional | 10/15/2015SE |
| K151322 | Amendia Interbody Fusion DevicesMAX · Traditional | 09/10/2015SE |
| K150395 | Omega LIF SystemMAX · Traditional | 08/10/2015SE |
Questions and answers
When was Amendia Interbody Fusion Devices cleared by the FDA?
Amendia Interbody Fusion Devices (K160924) received a 510(k) decision of Substantially Equivalent on November 8, 2016, 218 days after the submission was received.
What is the product code of K160924?
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.