510(k) K153735
K153735 is an FDA 510(k) premarket notification submitted by Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) for the device "Release Laminoplasty Fixation System". The FDA issued a decision of Substantially Equivalent on January 21, 2016. The device falls under product code NQW (Orthosis, Spine, Plate, Laminoplasty, Metal), a Class II device regulated under 21 CFR 888.3050. Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 21, 2016
- Date Received
- December 28, 2015
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Spine, Plate, Laminoplasty, Metal
- Device Class
- Class II
- Regulation Number
- 888.3050
- Review Panel
- OR
- Submission Type
This device is a plate that is attached to the lamina after a laminoplasty or laminectomy procedure.