510(k) K192718
K192718 is an FDA 510(k) premarket notification submitted by Pioneer Surgical Technology, Inc., Dba Rti Surgical, Inc. for the device "Fortilink Interbody Fusion Device (IBF) with TETRAfuse 3D Technology". The FDA issued a decision of Substantially Equivalent on Dec 20, 2019. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), 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
- Dec 20, 2019
- Date Received
- Sep 27, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intervertebral Fusion Device With Bone Graft, Lumbar
- Device Class
- Class II
- Regulation Number
- 888.3080
- Review Panel
- OR
- Submission Type
- 510(k)
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.