Ti-Diagon Oblique TLIF
FDA 510(k) K172064 · Camber Spine Technologies
510(k) numberK172064
Submission
- Device name
- Ti-Diagon Oblique TLIF
- Applicant
- Camber Spine Technologies
Wayne, PA, US - Received
- July 7, 2017
- Decision date
- September 15, 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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| 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 |
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More from Life Spine, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K234077 | SPIRA® Anterior Lumbar SpacersMAX · Traditional | 07/12/2024SE |
| K232256 | Alcantara Thoracolumbar Plate SystemKWQ · Traditional | 04/16/2024SE |
| K233972 | Camber Sacroiliac (SI) Fixation SystemOUR · Traditional | 02/27/2024SE |
| K230942 | SPIRA® Posterior Lumbar SpacersMAX · Traditional | 07/11/2023SE |
| K221324 | ENZA-O Titanium Lateral Anterior Lumbar Interbody Fusion (ALIF)OVD · Traditional | 03/30/2023SE |
| K223837 | SPIRA®-C Integrated Fixation SystemOVE · Traditional | 03/22/2023SE |
| K203503 | Camber Sacroiliac (SI) Fixation SystemOUR · Traditional | 09/02/2022SE |
| K220038 | Camber Spine Navigation SystemOLO · Traditional | 04/29/2022SE |
| K210595 | SPIRA-T Oblique Posterior Lumbar Spacers, SPIRA-P Posterior Lumbar SpacersMAX · Traditional | 06/15/2021SE |
| K193153 | SPIRA-C Integrated Fixation SystemOVE · Traditional | 04/24/2020SE |
Questions and answers
When was Ti-Diagon Oblique TLIF cleared by the FDA?
Ti-Diagon Oblique TLIF (K172064) received a 510(k) decision of Substantially Equivalent on September 15, 2017, 70 days after the submission was received.
What is the product code of K172064?
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.