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FDA 510(k)

CARES Screw - Retained Bars and Bridges (SRBB)

K-Number: K201711 · 2020-12-08

ApplicantMedentika GmbH
Decision Date2020-12-08
Product CodeNHA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CARES Screw - Retained Bars and Bridges (SRBB) is a medical device manufactured by Medentika GmbH. It received FDA 510(k) clearance on 2020-12-08 under approval number K201711. The device is classified under product code NHA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARES Screw - Retained Bars and Bridges (SRBB)?

CARES Screw - Retained Bars and Bridges (SRBB) is a medical device that received FDA 510(k) clearance on 2020-12-08. It is manufactured by Medentika GmbH. The 510(k) number is K201711.

When was CARES Screw - Retained Bars and Bridges (SRBB) approved by the FDA?

CARES Screw - Retained Bars and Bridges (SRBB) received FDA 510(k) clearance on 2020-12-08, under approval number K201711.

What company makes CARES Screw - Retained Bars and Bridges (SRBB)?

CARES Screw - Retained Bars and Bridges (SRBB) is manufactured by Medentika GmbH.

What is the FDA product code for CARES Screw - Retained Bars and Bridges (SRBB)?

The FDA product code for CARES Screw - Retained Bars and Bridges (SRBB) is NHA.

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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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