4CIS SARA Spine System, 4CIS VERTU Spine System— 510(k) K202498
Substantially EquivalentSolco Biomedical Company India Private Limited
FDA 510(k) clearance K202498 for 4CIS SARA Spine System, 4CIS VERTU Spine System, Substantially Equivalent on 2021-02-18. Applicant: Solco Biomedical Company India Private Limited. Device class: 2.
Clearance details
- Applicant
- Solco Biomedical Company India Private Limited
- Product code
- Code NKB
- Device class
- Class 2
- Regulation
- 21 CFR 888.3070
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Village-Rajpur, IN
Recent devices under product code NKB
view all- K262091 — FRAXION Spinal Fixation System
- K262193 — RIVA® Posterior Fixation System with NanoACTIV Surface Technology +1 more
- K262828 — KHEIRON® Spinal Fixation System, including patient specific K-ROD
- K253943 — Tiger 2 System
- K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Configuration)
More clearances from Solco Biomedical Company India Private Limited
view allAdverse events under product code NKB
product code NKB- Death
- 27
- Injury
- 5,033
- Malfunction
- 4,140
- Total
- 9,200
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.