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 Apr 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 34 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 17, 2018
- Date Received
- Jan 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
- 510(k)
Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft.