Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System
FDA 510(k) K233509 · Zavation Medical Products, LLC
510(k) numberK233509
Submission
- Device name
- Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System
- Applicant
- Zavation Medical Products, LLC
Flowood, MS, US - Received
- October 31, 2023
- Decision date
- April 10, 2024
- 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
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|---|---|---|---|
| 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 |
|---|---|---|
| K253943 | Tiger 2 SystemNKB · Traditional | 07/24/2026SE |
| K243908 | Tiger 2 SystemNKB · Traditional | 02/03/2025SE |
| K231811 | Zavation Connector SystemNKB · Traditional | 08/22/2023SE |
| K223808 | Zavation Navigation Instrument SystemOLO · Traditional | 07/12/2023SE |
| K230731 | Zavation ALIF SystemOVD · Traditional | 06/14/2023SE |
| K221726 | Uni-FuZe-C Bone StripMQV · Traditional | 01/18/2023SE |
| K222614 | Zavation Spinal SystemNKB · Traditional | 12/05/2022SE |
| K221049 | Zavation VariSync Plate System and VariSync Spacer SystemOVE · Traditional | 08/12/2022SE |
| K220581 | Zavation eZspand Interbody SystemMAX · Traditional | 06/02/2022SE |
| K212811 | Ti3Z Lumbar Interbody SystemMAX · Traditional | 04/12/2022SE |
Questions and answers
When was Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System cleared by the FDA?
Zavation IBF System, Zavation Varisync Plate System and Varisync Spacer System, LABYRINTH System, Zavation ALIF System (K233509) received a 510(k) decision of Substantially Equivalent on April 10, 2024, 162 days after the submission was received.
What is the product code of K233509?
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.