510(k) K162849
K162849 is an FDA 510(k) premarket notification submitted by Dio Medical Co., Ltd. for the device "Huvex Interspinous Fixation System". The FDA issued a decision of Substantially Equivalent on February 16, 2017. The device falls under product code PEK (Spinous Process Plate), a Class II device regulated under 21 CFR 888.3050. Dio Medical Co., Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 16, 2017
- Date Received
- October 11, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spinous Process Plate
- Device Class
- Class II
- Regulation Number
- 888.3050
- Review Panel
- OR
- Submission Type
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.