510(k) K152793
K152793 is an FDA 510(k) premarket notification submitted by Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. for the device "Unison-C Anterior Cervical Fixation System". The FDA issued a decision of Substantially Equivalent on Jan 19, 2016. The device falls under product code OVE (Intervertebral Fusion Device With Integrated Fixation, Cervical), a Class II device regulated under 21 CFR 888.3080. Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. has 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 19, 2016
- Date Received
- Sep 28, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intervertebral Fusion Device With Integrated Fixation, Cervical
- Device Class
- Class II
- Regulation Number
- 888.3080
- Review Panel
- OR
- Submission Type
- 510(k)
Intended to stabilize cervical spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.