Device type
Spinous Process Plate
Product code PEK · Class II · 21 CFR 888.3050 · Orthopedic
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)s
Oct 2, 2026
K261607
Minuteman G6 MIS Fusion Plate; Minuteman G5 MIS Fusion Plate; Minuteman G1 (Posterior Fusion Plate /HA Posterior Fusion Plate); HA Minuteman G3-R MIS Fusion Plate; Minuteman G3/HA Minuteman G3; Patriot SI Implant System; Liberty SI Lateral Implant System
Spinal Simplicity, LLC
- PEK
- Class II
Recent recalls
No recalls in the archive for PEK.