Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant System
FDA 510(k) K102090 · Spine Smith Partners L.P.
510(k) numberK102090
Submission
- Device name
- Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant System
- Applicant
- Spine Smith Partners L.P.
Austin, TX, US - Received
- July 26, 2010
- Decision date
- September 30, 2010
- 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.
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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 |
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| 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 |
|---|---|---|
| K122630 | IN:C2 Spinal Fixation SystemOVE · Special | 12/05/2012SE |
| K122168 | Visualif Challenging Access PlateOVD · Special | 10/11/2012SE |
| K101085 | Spinesmith Cynch Spinal SystemMAX · Special | 07/01/2010SE |
| K090376 | Spinesmith Cynch Spinal SystemMAX · Traditional | 04/01/2009SE |
| K082821 | Spinesmith Partners, LP Cequence Anterior Cervical Plate SystemKWQ · Traditional | 10/31/2008SE |
| K081132 | Spinesmith Partners, LP Cequence Anterior Cervical Plate SystemKWQ · Traditional | 07/14/2008SE |
| K080971 | Spinesmith Cimplicity Spinal SystemMQP · Traditional | 07/02/2008SE |
| K073320 | Cimplicity Spinal SystemODP · Traditional | 02/07/2008SE |
Questions and answers
When was Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant System cleared by the FDA?
Spinesmith Cynch Spinal System - Visualif Interbody Fusion Implant System (K102090) received a 510(k) decision of Substantially Equivalent on September 30, 2010, 66 days after the submission was received.
What is the product code of K102090?
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.