DeviceClearance

Product code PEK— Orthopedic

ZIP MIS INTERSPINOUS FUSION SYSTEM

Classification name
Spinous Process Plate
Device class
Class 2
Regulation
21 CFR 888.3050
Advisory panel
Orthopedic
Total cleared
48
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code PEK under 21 CFR 888.3050, via openFDA

Market context for product code PEK

FDA has cleared 48 devices under product code PEK between 2013 and 2025, filed by 32 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

Top applicants under product code PEK

Recent clearances under product code PEK

Data sourced from openFDA. This site is unofficial and independent of the FDA.