PEKClass IIImplant

Spinous Process Plate

Orthopedic · 21 CFR 888.3050

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.

MDR events61All time

Recalls1All time

Registered firms115Currently listed

510(k) clearances48All time

Recent MDR events

61 adverse event reports on file

Event type breakdown

Malfunction51

Injury10

Most-reported manufacturers

Xtant Medical Holdings, Inc.18 Xtant Medical8 Seaspine Orthopedics Corporation6 Aurora Spine5 X-spine Systems, Inc.4 Aurora Spine, Inc.2 Nuvasive2 Nuvasive, Inc.2

Recalls

1 recall events for this product code

XTANT Medical
TerminatedUnknown
X060-0270, 8mm Titanium Insert, Axle Interspinous Fusion System.
The proximal opening of the inserts exhibit an out of specification condition which would prevent the crossbar plates from appropriately engaging with the insert.
Z-0533-2022 · View FDA record ↗

Registered firms

115 firms currently registered for this product code

510(k) clearances

48 clearances for this product code