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FDA 510(k)

Simplify Disc

K-Number: K211757 · 2021-08-20

ApplicantNuvasive, Inc.
Decision Date2021-08-20
Product CodeQLQ
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Simplify Disc is the device name listed in this FDA 510(k) record. The listed applicant is Nuvasive, Inc.. It received FDA 510(k) clearance on 2021-08-20 under 510(k) number K211757. The device is classified under product code QLQ. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Simplify Disc?

Simplify Disc is a medical device that received FDA 510(k) clearance on 2021-08-20. The listed applicant is Nuvasive, Inc.. The 510(k) number is K211757.

When did Simplify Disc receive FDA 510(k) clearance?

Simplify Disc received FDA 510(k) clearance on 2021-08-20, under 510(k) number K211757.

Who is the listed applicant for Simplify Disc?

The FDA 510(k) record lists Nuvasive, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Simplify Disc?

The FDA product code for Simplify Disc is QLQ.

Other records listing Nuvasive, Inc. as applicant

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Related Devices (Code: QLQ)

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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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