Proposed Optimus
FDA 510(k) K132596 · Custom Spine, Inc.
510(k) numberK132596
Submission
- Device name
- Proposed Optimus
- Applicant
- Custom Spine, Inc.
Parsippany, NJ, US - Received
- August 19, 2013
- Decision date
- April 11, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
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| 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 |
| K090566 | Pathway AvidMAX · Traditional | 06/01/2009SE |
| K080281 | PathwayMAX · Traditional | 05/01/2008SE |
Questions and answers
When was Proposed Optimus cleared by the FDA?
Proposed Optimus (K132596) received a 510(k) decision of Substantially Equivalent on April 11, 2014, 235 days after the submission was received.
What is the product code of K132596?
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.