Crossfuse II Coronal Taper, Crossfuse II Hyperlordotic
FDA 510(k) K133455 · Pioneer Surgical Technology, Inc.
510(k) numberK133455
Submission
- Device name
- Crossfuse II Coronal Taper, Crossfuse II Hyperlordotic
- Applicant
- Pioneer Surgical Technology, Inc.
Marquette, MI, US - Received
- November 12, 2013
- Decision date
- March 27, 2014
- 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
| 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 |
|---|---|---|
| K261271 | Cable-Ready® Cable Grip SystemJDQ · Traditional | 07/16/2026SE |
| K251436 | Resolve Anterior Cervical Plate SystemKWQ · Abbreviated | 07/11/2025SE |
| K222493 | CODA Anterior Cervical Plate SystemKWQ · Traditional | 11/18/2022SE |
| K211408 | CervAlign® Anterior Cervical Plate SystemKWQ · Traditional | 06/23/2021SE |
| K192396 | Streamline MIS Spinal Fixation SystemNKB · Traditional | 11/26/2019SE |
| K140696 | Streamline TL Spinal Fixation SystemNKB · Special | 04/10/2014SE |
| K133623 | C-PlusODP · Traditional | 02/10/2014SE |
| K132050 | NB3D Bone Void FillerMQV · Traditional | 02/07/2014SE |
| K133785 | Tritium Sternal Cable Plate SystemJDQ · Traditional | 01/27/2014SE |
| K131724 | Pioneer Maxfuse Vertebral Body Replacement DeviceMQP · Traditional | 12/24/2013SE |
Questions and answers
When was Crossfuse II Coronal Taper, Crossfuse II Hyperlordotic cleared by the FDA?
Crossfuse II Coronal Taper, Crossfuse II Hyperlordotic (K133455) received a 510(k) decision of Substantially Equivalent on March 27, 2014, 135 days after the submission was received.
What is the product code of K133455?
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.