Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System
FDA 510(k) K201506 · Meditech Spine, LLC
510(k) numberK201506
Submission
- Device name
- Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System
- Applicant
- Meditech Spine, LLC
Atlanta, GA, US - Received
- June 5, 2020
- Decision date
- September 11, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K210286 | Cure 2.0 Anterior Cervical Plate (ACP) SystemKWQ · Special | 03/18/2021SE |
| K201136 | Cure Lumbar Plate SystemKWQ · Special | 05/12/2020SE |
| K181543 | Cure OPEL-C Plate SystemKWQ · Traditional | 08/31/2018SE |
| K180090 | Cure Lumbar Plate SystemKWQ · Special | 04/23/2018SE |
| K171538 | Cure Lumbar Plate SystemKWQ · Traditional | 06/16/2017SE |
| K170395 | Talos® Lumbar (HA) PEEK IBF DevicesMAX · Traditional | 06/02/2017SE |
| K160604 | Cure Anterior Cervical Plate (ACP) SystemKWQ · Traditional | 07/01/2016SE |
| K150788 | Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion…ODP · Traditional | 10/14/2015SE |
| K142345 | Talos-C(HA) Cervical Intervertebral Body Fusion DevicesODP · Traditional | 02/22/2015SE |
Questions and answers
When was Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System cleared by the FDA?
Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical Intervertebral Body Fusion System (K201506) received a 510(k) decision of Substantially Equivalent on September 11, 2020, 98 days after the submission was received.
What is the product code of K201506?
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.