4WEB Spinal Implant Products
FDA 510(k) K142112 · 4Web, Inc.
510(k) numberK142112
Submission
- Device name
- 4WEB Spinal Implant Products
- Applicant
- 4Web, Inc.
Fr. Myers, FL, US - Received
- August 4, 2014
- Decision date
- September 23, 2014
- 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.
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 |
|---|---|---|
| K253201 | Lumbar Spine Truss System - Plating Solution (LSTS-PS)KWQ · Special | 02/12/2026SE |
| K203065 | Lumbar Spine Truss System Plating Solution (LSTS-PS)KWQ · Traditional | 03/10/2021SE |
| K200002 | Anterior Spine Truss System Stand Alone (ASTS-SA) Interbody Fusion DeviceOVD · Traditional | 05/29/2020SE |
| K190870 | Cervical Spinal Truss System-Stand Alone (CSTS-SA)OVE · Traditional | 08/12/2019SE |
| K190926 | Hammertoe Truss System (HTS)HTY · Traditional | 07/23/2019SE |
| K172294 | Osteotomy Truss System (OTS)HRS · Traditional | 02/22/2018SE |
| K173159 | Cervical Spinal Truss System (CSTS) Interbody Fusion DeviceODP · Traditional | 01/08/2018SE |
| K172392 | Lateral Spinal Truss System (LSTS) Interbody Fusion DeviceMAX · Traditional | 11/07/2017SE |
| K171351 | Posterior Spine Truss System (PSTS) Interbody Fusion DeviceMAX · Traditional | 09/08/2017SE |
| K170851 | Anterior Spine Truss System (STS) Interbody Fusion DeviceMAX · Traditional | 08/07/2017SE |
Questions and answers
When was 4WEB Spinal Implant Products cleared by the FDA?
4WEB Spinal Implant Products (K142112) received a 510(k) decision of Substantially Equivalent on September 23, 2014, 50 days after the submission was received.
What is the product code of K142112?
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.