510(k) K173947
K173947 is an FDA 510(k) premarket notification submitted by Advanced Research Medical, LLC for the device "Lumbar Interbody Fusion System (OLLIF)". The FDA issued a decision of Substantially Equivalent on July 25, 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. Advanced Research Medical, LLC has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 25, 2018
- Date Received
- December 27, 2017
- 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.