510(k) K180078
K180078 is an FDA 510(k) premarket notification submitted by Innovasis, Inc. for the device "Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System". The FDA issued a decision of Substantially Equivalent on April 17, 2018. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Innovasis, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 17, 2018
- Date Received
- January 10, 2018
- 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
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.