Arco-SA Lumbar Cage System
FDA 510(k) K173082 · Neurostructures, Inc.
510(k) numberK173082
Submission
- Device name
- Arco-SA Lumbar Cage System
- Applicant
- Neurostructures, Inc.
Irvine, CA, US - Received
- September 29, 2017
- Decision date
- March 29, 2018
- 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.
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|---|---|---|---|
| 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 |
|---|---|---|
| K202190 | Oculus-SA Lumbar Cage SystemOVD · Traditional | 10/02/2020SE |
| K200115 | Cavetto-SA Cervical Cage SystemOVE · Special | 09/24/2020SE |
| K201769 | Cavetto [MAX] Cervical Cage SystemODP · Traditional | 09/03/2020SE |
| K200927 | Transept Cervical Plate SystemKWQ · Traditional | 07/24/2020SE |
| K192248 | Cortina [MAX] Lumbar Cage SystemMAX · Special | 11/25/2019SE |
| K182195 | Arco-SA Lumbar Cage SystemOVD · Special | 11/09/2018SE |
| K181590 | Neurostructures Cavetto® [MAX] Cervical Cage SystemODP · Special | 11/08/2018SE |
| K180431 | Cortina [MAX] Lumbar Cage SystemMAX · Traditional | 03/22/2018SE |
| K172320 | Neurostructures Cavetto® Cervical Cage SystemODP · Traditional | 02/26/2018SE |
| K173077 | Cavetto-SA Cervical Cage SystemOVE · Traditional | 02/23/2018SE |
Questions and answers
When was Arco-SA Lumbar Cage System cleared by the FDA?
Arco-SA Lumbar Cage System (K173082) received a 510(k) decision of Substantially Equivalent on March 29, 2018, 181 days after the submission was received.
What is the product code of K173082?
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.