FDA 510(k)

Simplify Disc

K-Number: K211757 · 2021-08-20

Decision Date2021-08-20

Product CodeQLQ

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

Simplify Disc is a medical device manufactured by Nuvasive, Inc.. It received FDA 510(k) clearance on 2021-08-20 under approval 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. It is manufactured by Nuvasive, Inc.. The 510(k) number is K211757.

When was Simplify Disc approved by the FDA?

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

What company makes Simplify Disc?

Simplify Disc is manufactured by Nuvasive, Inc..

What is the FDA product code for Simplify Disc?

The FDA product code for Simplify Disc is QLQ.

Other Devices by Nuvasive, Inc.

K173117NuVasive® VersaTie System K223731NuVasive Modulus-C Interbody System K240507NuVasive AttraX Scaffold PMA P100012Prosthesis, intervertebral disc PMA P200022Prosthesis, intervertebral disc

Related Devices (Code: QLQ)

K221848prodisc C SK, prodisc C Nova, and prodisc C Vivo InstrumentsCentinel Spine, LLC K220861M6-C Artificial Cervical Disc Instruments ASSpinal Kinetics, LLC K231769activL® Next Generation InstrumentationAesculap Implants Systems, LLC K242869prodisc® L InstrumentsCentinel Spine, LLC K241117M6-C Single Use, Disposable InstrumentationSpinal Kinetics / Orthofix / Seaspine K250554prodisc® L InstrumentsCentinel Spine, LLC

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.