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FDA 510(k)

4CIS SARA Spine System, 4CIS VERTU Spine System

K-Number: K202498 · 2021-02-18

ApplicantSolco Biomedical Company India Private Limited
Decision Date2021-02-18
Product CodeNKB
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

4CIS SARA Spine System, 4CIS VERTU Spine System is a medical device manufactured by Solco Biomedical Company India Private Limited. It received FDA 510(k) clearance on 2021-02-18 under approval number K202498. The device is classified under product code NKB. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 4CIS SARA Spine System, 4CIS VERTU Spine System?

4CIS SARA Spine System, 4CIS VERTU Spine System is a medical device that received FDA 510(k) clearance on 2021-02-18. It is manufactured by Solco Biomedical Company India Private Limited. The 510(k) number is K202498.

When was 4CIS SARA Spine System, 4CIS VERTU Spine System approved by the FDA?

4CIS SARA Spine System, 4CIS VERTU Spine System received FDA 510(k) clearance on 2021-02-18, under approval number K202498.

What company makes 4CIS SARA Spine System, 4CIS VERTU Spine System?

4CIS SARA Spine System, 4CIS VERTU Spine System is manufactured by Solco Biomedical Company India Private Limited.

What is the FDA product code for 4CIS SARA Spine System, 4CIS VERTU Spine System?

The FDA product code for 4CIS SARA Spine System, 4CIS VERTU Spine System is NKB.

Related Clinical Trials

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Other Devices by Solco Biomedical Company India Private Limited

K2136534CIS BLACK MARLIN PLIF CAGE SYSTEM, 4CIS DOLPHIN TLIF CAGE 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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