510(k) K221182
K221182 is an FDA 510(k) premarket notification submitted by Southern Medical (Pty) , Ltd. for the device "Southern Transforaminal Lumbar Interbody Fusion (TLIF)". The FDA issued a decision of Substantially Equivalent on Dec 8, 2022. The device falls under product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar), a Class II device regulated under 21 CFR 888.3080. Southern Medical (Pty) , Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 8, 2022
- Date Received
- Apr 25, 2022
- 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.