TELIX K Interbody System
FDA 510(k) K170890 · Biedermann Motech GmbH & Co. KG
510(k) numberK170890
Submission
- Device name
- TELIX K Interbody System
- Applicant
- Biedermann Motech GmbH & Co. KG
Villingen-Schwenningen, DE - Received
- March 27, 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.
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|---|---|---|---|
| K261049 | Scala® TLMAX · Traditional | Spineart SA | 08/20/2026SE |
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| 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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| K203607 | MOSS VRS Spinal SystemNKB · Traditional | 08/20/2021SE |
| K181821 | MOSS VRS Spinal SystemNKB · Traditional | 09/13/2018SE |
| K162232 | MOSS 100 Pedicle Screw SystemNKB · Traditional | 11/17/2016SE |
| K894184 | Biedermann Motech Universal Spinal SystemJDN · Traditional | 04/25/1990SN |
| K900138 | Motech Titanium Surgical MeshEZX · Traditional | 03/20/1990SE |
Questions and answers
When was TELIX K Interbody System cleared by the FDA?
TELIX K Interbody System (K170890) received a 510(k) decision of Substantially Equivalent on June 2, 2017, 67 days after the submission was received.
What is the product code of K170890?
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.