PEK — Spinous Process Plate Class II
Classification Details
- Product Code
- PEK
- Device Class
- Class II
- Regulation Number
- 888.3050
- Submission Type
- Review Panel
- OR
- Medical Specialty
- Orthopedic
- Implant
- Yes
Definition
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 radiographic studies), Trauma (i.e., fracture or dislocation), Spondylolisthesis, and/or Tumor. It is not intended for stand-alone use.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253250 | spinal simplicity | Minuteman® G6 MIS Fusion Plate | December 1, 2025 |
| K234051 | spinal simplicity | Minuteman G5 MIS Fusion Plate; Minuteman G1(Posterior Fusion Plate /HA Posterior | January 18, 2024 |
| K233527 | spinal simplicity | Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterio | November 29, 2023 |
| K232484 | flospine | KeyLift Expandable Interlaminar Stabilization System | October 19, 2023 |
| K231807 | wenzel spine | primaLOK SP Interspinous Fusion System | August 15, 2023 |
| K223790 | dio medical | Huvex Interspinous Fusion System | March 9, 2023 |
| K221023 | spinal simplicity | Posterior Fusion Plate/HA Posterior Fusion Plate (Minuteman G1), Minuteman G3/HA | August 19, 2022 |
| K221399 | aurora spine | ZIP MIS Interspinous Fusion System | July 8, 2022 |
| K211880 | spinal simplicity | Minuteman G5 MIS Fusion Plate | March 11, 2022 |
| K212781 | spinal simplicity | Posterior Fusion Plate/HA Posterior Fusion Plate, Minuteman G3 MIS Fusion Plate, | December 15, 2021 |
| K213266 | lespine innovations | Inspan ScrewLES Fusion System | December 3, 2021 |
| K200066 | spinal simplicity | Posterior Fusion Plate, HA Posterior Fusion Plate | December 10, 2020 |
| K201704 | paradigm spine | CoFix System | August 4, 2020 |
| K182352 | medical designs | SP-LINK System | November 21, 2018 |
| K180817 | globus medical | AERIAL Interspinous Fixation | May 21, 2018 |
| K180156 | globus medical | SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System | March 7, 2018 |
| K173334 | seaspine orthopedics corporation | SeaSpine Spinous Process System | February 22, 2018 |
| K163471 | kalitec direct | Kalitec Direct InSePtion MIS Fixation System | March 16, 2017 |
| K162849 | dio medical co | Huvex Interspinous Fixation System | February 16, 2017 |
| K163428 | spinal simplicity | HA Minuteman G3-R MIS Fusion Plate | February 2, 2017 |