Talos® Lumbar (HA) PEEK IBF Devices
FDA 510(k) K170395 · Meditech Spine, LLC
510(k) numberK170395
Submission
- Device name
- Talos® Lumbar (HA) PEEK IBF Devices
- Applicant
- Meditech Spine, LLC
Atlanta, GA, US - Received
- February 8, 2017
- Decision date
- June 2, 2017
- 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K210286 | Cure 2.0 Anterior Cervical Plate (ACP) SystemKWQ · Special | 03/18/2021SE |
| K201506 | Talos®-C Cervical Intervertebral Body Fusion System, Talos®-C (HA) Cervical…ODP · Special | 09/11/2020SE |
| 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 |
| 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® Lumbar (HA) PEEK IBF Devices cleared by the FDA?
Talos® Lumbar (HA) PEEK IBF Devices (K170395) received a 510(k) decision of Substantially Equivalent on June 2, 2017, 114 days after the submission was received.
What is the product code of K170395?
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.