icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn TLIF Lumbar Cage)
FDA 510(k) K232792 · Icotec AG
510(k) numberK232792
Submission
- Device name
- icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn TLIF Lumbar Cage)
- Applicant
- Icotec AG
9450 Altstaetten (Sg), CH - Received
- September 11, 2023
- Decision date
- April 5, 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.
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| K261049 | Scala® TLMAX · Traditional | Spineart SA | 08/20/2026SE |
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| 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 |
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| K252327 | CMORE® CT System; CMORE® CT System Navigated InstrumentsNKG · Traditional | 11/12/2025SE |
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| K233215 | icotec Anterior Cervical Plate SystemKWQ · Traditional | 05/17/2024SE |
| K232790 | KONG®-TL VBR System and KONG® C VBR SystemMQP · Traditional | 04/04/2024SE |
| K232628 | VADER® Pedicle SystemNKB · Traditional | 02/26/2024SE |
| K230861 | VADER® Pedicle System Navigated InstrumentsOLO · Traditional | 06/27/2023SE |
| K222789 | VADER® Pedicle System, G21 CementPML · Traditional | 01/09/2023SE |
| K201587 | icotec Anterior Cervical Plate SystemKWQ · Traditional | 10/15/2020SE |
| K200596 | G21 Cement, VADER® Pedicle SystemPML · Traditional | 10/13/2020SE |
| K200235 | KONG-TL VBR System, KONG-C VBR SystemMQP · Traditional | 05/29/2020SE |
Questions and answers
When was icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn TLIF Lumbar Cage) cleared by the FDA?
icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec ETurn TLIF Lumbar Cage) (K232792) received a 510(k) decision of Substantially Equivalent on April 5, 2024, 207 days after the submission was received.
What is the product code of K232792?
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.