Reliance Lumber IBF System
FDA 510(k) K180687 · Reliance Medical Systems
510(k) numberK180687
Submission
- Device name
- Reliance Lumber IBF System
- Applicant
- Reliance Medical Systems
Bountiful, UT, US - Received
- March 15, 2018
- Decision date
- May 15, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
| 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 |
|---|---|---|
| K202266 | Reliance Cervical IBF SystemODP · Traditional | 03/29/2022SE |
| K210874 | Reliance Spinal Screw SystemNKB · Special | 05/13/2021SE |
| K183049 | Reliance Lumbar IBF SystemMAX · Special | 02/15/2019SE |
| K181118 | Reliance Lumbar IBF SystemOVD · Traditional | 01/09/2019SE |
| K173283 | Reliance Lumbar IBF SystemMAX · Special | 01/19/2018SE |
| K173102 | Reliance Cervical IBF SystemODP · Special | 12/29/2017SE |
| K172489 | Reliance Cervical IBF SystemODP · Special | 09/07/2017SE |
| K162066 | Reliance Spinal Screw SystemMNH · Traditional | 12/02/2016SE |
| K160463 | Reliance Lumbar IBF SystemMAX · Special | 05/20/2016SE |
| K152131 | Reliance Spinal Screw SystemMNI · Special | 09/17/2015SE |
Questions and answers
When was Reliance Lumber IBF System cleared by the FDA?
Reliance Lumber IBF System (K180687) received a 510(k) decision of Substantially Equivalent on May 15, 2018, 61 days after the submission was received.
What is the product code of K180687?
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.