4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM
FDA 510(k) clearance K213653 · decided 2022-12-19
Clearance details
- K-number
- K213653
- Device name
- 4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM
- Applicant
- Solco Biomedical Company India Private Limited
- Decision
- Substantially Equivalent
- Date received
- 2021-11-19
- Decision date
- 2022-12-19
- Days to decision
- 395 days
- Clearance type
- Traditional
- Product code
- MAX
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Ahmedabad, IN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.