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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 the device name listed in this FDA 510(k) record. The listed applicant is Solco Biomedical Company India Private Limited. It received FDA 510(k) clearance on 2022-12-19 under 510(k) 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. The listed applicant is Solco Biomedical Company India Private Limited. The 510(k) number is K213653.

When did 4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM receive FDA 510(k) clearance?

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

Who is the listed applicant for 4CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE SYSTEM?

The FDA 510(k) record lists Solco Biomedical Company India Private Limited as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Solco Biomedical Company India Private Limited as applicant

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Official Source

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

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