510(k) K202498
K202498 is an FDA 510(k) premarket notification submitted by Solco Biomedical Company India Private Limited for the device "4CIS SARA Spine System, 4CIS VERTU Spine System". The FDA issued a decision of Substantially Equivalent on Feb 18, 2021. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Solco Biomedical Company India Private Limited has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 18, 2021
- Date Received
- Aug 31, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Thoracolumbosacral Pedicle Screw System
- Device Class
- Class II
- Regulation Number
- 888.3070
- Review Panel
- OR
- Submission Type
- 510(k)
Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.