icotec Cervical Cage
FDA 510(k) K192897 · Icotec AG
510(k) numberK192897
Submission
- Device name
- icotec Cervical Cage
- Applicant
- Icotec AG
9450 Altstaetten (Sg), CH - Received
- October 11, 2019
- Decision date
- March 20, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ODP – Intervertebral Fusion Device With Bone Graft, Cervical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3080
- Specialty
- Orthopedic
- Implant
- Yes
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.
Other 510(k)s with product code ODP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262595 | VariLift-C Cervical Interbody Fusion SystemODP · Special | Wenzel Spine, Inc. | 08/26/2026SE |
| K262489 | BluEX Cervical Expandable Cage SystemODP · Special | L&K BIOMED Co., Ltd. | 08/18/2026SE |
| K253041 | 3d Cage CervicalODP · Traditional | Fims Co., Ltd. | 07/23/2026SE |
| K262061 | Tritanium® C Anterior Cervical Cage; Tritanium® PL Cage; Tritanium® TL Curved Posterior…ODP · Special | Stryker Spine | 07/17/2026SE |
| K254130 | C.A. Medical Interbody Fusion SystemODP · Special | C.A. Medical, LLC | 07/08/2026SE |
| K260840 | BluEX Cervical Expandable Cage SystemODP · Traditional | L&K BIOMED Co., Ltd. | 05/16/2026SE |
| K260850 | Osteomni Spinal Cages SystemODP · Traditional | Osteomni, Inc. | 05/12/2026SE |
| K260549 | ZSFab Cervical Interbody System and ZSFab Lumbar Interbody SystemODP · Special | Zsfab, Inc. | 04/24/2026SE |
| K253260 | ORIO-3D Cage SystemODP · Traditional | SpineCraft | 04/16/2026SE |
| K260340 | HC Biologics Osteopoint PEEK Cages, HC Biologics Osteopoint Cervical PEEK Cages, HC…ODP · Traditional | HC Biologics, LLC | 04/13/2026SE |
More from HC Biologics, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K252327 | CMORE® CT System; CMORE® CT System Navigated InstrumentsNKG · Traditional | 11/12/2025SE |
| K242900 | VADER® Pedicle System and VADER®one Pedicle SystemNKB · Traditional | 02/27/2025SE |
| K233215 | icotec Anterior Cervical Plate SystemKWQ · Traditional | 05/17/2024SE |
| K232792 | icotec Interbody Cage System (icotec Cervical Cage, icotec PLIF Lumbar Cage, icotec…MAX · Traditional | 04/05/2024SE |
| 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 |
Questions and answers
When was icotec Cervical Cage cleared by the FDA?
icotec Cervical Cage (K192897) received a 510(k) decision of Substantially Equivalent on March 20, 2020, 161 days after the submission was received.
What is the product code of K192897?
The FDA product code is ODP – Intervertebral Fusion Device With Bone Graft, Cervical, a Class II (moderate risk) device regulated under 21 CFR 888.3080.