primaLOK SP Interspinous Fusion System
FDA 510(k) K231807 · Wenzel Spine, Inc.
510(k) numberK231807
Submission
- Device name
- primaLOK SP Interspinous Fusion System
- Applicant
- Wenzel Spine, Inc.
Austin, TX, US - Received
- June 20, 2023
- Decision date
- August 15, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- PEK – Spinous Process Plate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3050
- Specialty
- Orthopedic
- Implant
- Yes
A posterior, non-pedicle supplemental fixation device intended for single level use in the non-cervical spine (T1-S1). It is intended for single level plate fixation/attachment to spinous process for the purpose of achieving supplemental fusion in the following conditions: Degenerative Disc Disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and…
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| K223790 | Huvex Interspinous Fusion SystemPEK · Traditional | Dio Medical Corp. | 03/09/2023SE |
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| K221399 | ZIP MIS Interspinous Fusion SystemPEK · Traditional | Aurora Spine, Inc. | 07/08/2022SE |
| K211880 | Minuteman G5 MIS Fusion PlatePEK · Traditional | Spinal Simplicity, LLC | 03/11/2022SE |
| K212781 | Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, HA…PEK · Traditional | Spinal Simplicity, LLC | 12/15/2021SE |
| K213266 | Inspan ScrewLES Fusion SystemPEK · Traditional | Lespine Innovations, LLC | 12/03/2021SE |
More from Lespine Innovations, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K262595 | VariLift-C Cervical Interbody Fusion SystemODP · Special | 08/26/2026SE |
| K250247 | panaSIa SI Fusion SystemOUR · Traditional | 07/09/2025SE |
| K231076 | VariLift®-C Interbody Fusion SystemODP · Traditional | 09/27/2023SE |
| K180822 | VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion SystemMAX · Traditional | 01/28/2019SE |
| K151900 | VariLift-L Interbody Fusion DeviceMAX · Traditional | 12/11/2015SE |
| K131296 | Varilift-L Interbody Fusion DeviceMAX · Traditional | 09/03/2013SE |
| K120603 | Varilift -CODP · Traditional | 01/29/2013SE |
| K111123 | Varilift Cervical Interbody Fusion SystemODP · Traditional | 12/08/2011SE |
| K100820 | Wenzel Spine Varilift Interbody Fusion SystemMAX · Traditional | 08/05/2010SE |
Questions and answers
When was primaLOK SP Interspinous Fusion System cleared by the FDA?
primaLOK SP Interspinous Fusion System (K231807) received a 510(k) decision of Substantially Equivalent on August 15, 2023, 56 days after the submission was received.
What is the product code of K231807?
The FDA product code is PEK – Spinous Process Plate, a Class II (moderate risk) device regulated under 21 CFR 888.3050.