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FDA 510(k)

4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM

K-Number: K213653 · 2022-12-19

ApplicantSolco Biomedical Company India Private Limited
Decision Date2022-12-19
Product CodeMAX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM is a medical device manufactured by Solco Biomedical Company India Private Limited. It received FDA 510(k) clearance on 2022-12-19 under approval number K213653. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM?

4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM is a medical device that received FDA 510(k) clearance on 2022-12-19. It is manufactured by Solco Biomedical Company India Private Limited. The 510(k) number is K213653.

When was 4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM approved by the FDA?

4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM received FDA 510(k) clearance on 2022-12-19, under approval number K213653.

What company makes 4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM?

4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM is manufactured by Solco Biomedical Company India Private Limited.

What is the FDA product code for 4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM?

The FDA product code for 4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM is MAX.

Related Clinical Trials

NCT05856799 Danish Randomized Trial on Leadless vs Transvenous Pacing ACTIVE_NOT_RECRUITING

Other Devices by Solco Biomedical Company India Private Limited

K2024984CIS SARA Spine System, 4CIS VERTU Spine System

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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