4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM— 510(k) K213653
Substantially EquivalentSolco Biomedical Company India Private Limited
FDA 510(k) clearance K213653 for 4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM, Substantially Equivalent on 2022-12-19. Applicant: Solco Biomedical Company India Private Limited.
Clearance details
- Applicant
- Solco Biomedical Company India Private Limited
- Product code
- Code MAX
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ahmedabad, IN
Adverse events under product code MAX
product code MAX- Death
- 13
- Injury
- 1,305
- Malfunction
- 2,885
- Total
- 4,203
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.