Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar Ibf
FDA 510(k) K083798 · Medicrea Technologies
510(k) numberK083798
Submission
- Device name
- Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar Ibf
- Applicant
- Medicrea Technologies
Douglassville, PA, US - Received
- December 22, 2008
- Decision date
- May 19, 2010
- 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
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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 |
|---|---|---|
| K102406 | Pass Anterior Spinal SystemKWQ · Traditional | 08/23/2011SE |
| K100544 | Impix Lumbar Interbody DeviceMAX · Special | 07/22/2010SE |
| K100297 | Pass LP Spinal SystemMNI · Traditional | 03/04/2010SE |
| K083810 | Pass LP Spinal SystemMNI · Special | 07/31/2009SE |
| K083308 | Pass LP Spinal SystemMNI · Special | 12/10/2008SE |
| K082577 | Pass LP Spinal SystemMNH · Special | 10/03/2008SE |
| K082069 | Pass 2 Spinal SystemMNI · Special | 10/03/2008SE |
| K080099 | Pass Spinal SystemMNI · Special | 04/09/2008SE |
| K072226 | Impix SpacerMAX · Traditional | 12/10/2007SE |
| K070530 | Modification to Passmed Spinal SystemMNH · Special | 10/18/2007SE |
Questions and answers
When was Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar Ibf cleared by the FDA?
Impix Alif Lumbar Ibf, Impix Alif-D Lumbar Ibf, Impix Tlif Lumbar Ibf (K083798) received a 510(k) decision of Substantially Equivalent on May 19, 2010, 513 days after the submission was received.
What is the product code of K083798?
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.