510(k) K213935
K213935 is an FDA 510(k) premarket notification submitted by Osseus Fusion Systems for the device "PISCES-SA Standalone ALIF Interbody System". The FDA issued a decision of Substantially Equivalent on May 6, 2022. The device falls under product code OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar), a Class II device regulated under 21 CFR 888.3080. Osseus Fusion Systems has 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 6, 2022
- Date Received
- Dec 16, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Intervertebral Fusion Device With Integrated Fixation, Lumbar
- Device Class
- Class II
- Regulation Number
- 888.3080
- Review Panel
- OR
- Submission Type
- 510(k)
Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation.