Optimus ALIF System
FDA 510(k) K160291 · Amendia, Inc.
510(k) numberK160291
Submission
- Device name
- Optimus ALIF System
- Applicant
- Amendia, Inc.
Marietta, GA, US - Received
- February 3, 2016
- Decision date
- February 18, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.
Other 510(k)s with product code OVD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262025 | Innovasis AxTiHA® Stand-Alone ALIF System;Innovasis TxTiHA® IBF System;Innovasis…OVD · Traditional | INNO Holdings Inc. DBA Innovasis | 09/11/2026SE |
| K261408 | SABER-XA SystemOVD · Traditional | Elevation Spine | 08/03/2026SE |
| K261809 | Interwedge® Standalone LateralOVD · Special | Foundation Surgical Group | 07/31/2026SE |
| K261353 | Tesera-K Anterior Lumbar Interbody Fusion (ALIF) System; Tesera-K XL System; Lumbar…OVD · Traditional | Kyocera Medical Technologies, Inc. | 07/15/2026SE |
| K260810 | Anteralign LS coverplateOVD · Traditional | Tyber Medical, LLC | 06/10/2026SE |
| K254202 | MectaLIF 3D Metal AnteriorOVD · Traditional | Medacta International S.A. | 05/05/2026SE |
| K253401 | SCRIPT Implant SystemOVD · Traditional | Globus Medical, Inc. | 04/29/2026SE |
| K253559 | Ventana A Anterior Lumbar Interbody SystemOVD · Traditional | Spinal Elements, Inc. | 02/25/2026SE |
| K251829 | DeGen Medical Patient Specific Implant (PSI) SystemOVD · Traditional | Degen Medical | 12/08/2025SE |
| K251575 | IdentiTi II ALIF Standalone Interbody System; Transcend ALIF Standalone Interbody SystemOVD · Traditional | Alphatec Spine | 09/03/2025SE |
More from Alphatec Spine
| 510(k) | Device | Decision |
|---|---|---|
| K160924 | Amendia Interbody Fusion DevicesMAX · Traditional | 11/08/2016SE |
| 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 |
| 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 Optimus ALIF System cleared by the FDA?
Optimus ALIF System (K160291) received a 510(k) decision of Substantially Equivalent on February 18, 2016, 15 days after the submission was received.
What is the product code of K160291?
The FDA product code is OVD – Intervertebral Fusion Device With Integrated Fixation, Lumbar, a Class II (moderate risk) device regulated under 21 CFR 888.3080.