PEK · Class II — Moderate Risk (510(k) clearance required) · Orthopedic · 21 CFR 888.3050
Classification
FDA Product Code
PEK
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 888.3050
Review panel
OR
Medical specialty
Orthopedic
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N
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.