4CIS SARA Spine System, 4CIS VERTU Spine System
FDA 510(k) clearance K202498 · decided 2021-02-18
Clearance details
- K-number
- K202498
- Device name
- 4CIS SARA Spine System, 4CIS VERTU Spine System
- Applicant
- Solco Biomedical Company India Private Limited
- Decision
- Substantially Equivalent
- Date received
- 2020-08-31
- Decision date
- 2021-02-18
- Days to decision
- 171 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Village-Rajpur, IN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.