510(k) K213653
K213653 is an FDA 510(k) premarket notification submitted by Solco Biomedical Company India Private Limited for the device "4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM". The FDA issued a decision of Substantially Equivalent on Dec 19, 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. Solco Biomedical Company India Private Limited has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Dec 19, 2022
- Date Received
- Nov 19, 2021
- 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.