Simplify Disc
FDA 510(k) K211757 · Nuvasive, Inc.
510(k) numberK211757
Submission
- Device name
- Simplify Disc
- Applicant
- Nuvasive, Inc.
Sunnyvale, CA, US - Received
- June 7, 2021
- Decision date
- August 20, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QLQ – Manual Instruments Designed For Use With Total Disc Replacement Devices
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.4515
- Specialty
- Orthopedic
The devices are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of total disc replacement devices.
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| K253392 | Synergy Disc InstrumentsQLQ · Traditional | Synergy Spine Solutions, Inc. | 03/27/2026SE |
| K250554 | prodisc® L InstrumentsQLQ · Traditional | Centinel Spine, LLC | 04/25/2025SE |
| K242869 | prodisc® L InstrumentsQLQ · Traditional | Centinel Spine, LLC | 12/17/2024SE |
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| K231769 | activL® Next Generation InstrumentationQLQ · Special | Aesculap Implants Systems, LLC | 07/13/2023SE |
| K221848 | prodisc C SK, prodisc C Nova, and prodisc C Vivo InstrumentsQLQ · Traditional | Centinel Spine, LLC | 08/19/2022SE |
| K220861 | M6-C Artificial Cervical Disc Instruments ASQLQ · Traditional | Spinal Kinetics, LLC | 06/02/2022SE |
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| K141968 | Nuvasive NVM5 SystemPDQ · Traditional | 11/14/2014SE |
| K140319 | Coroent Ti-C SystemMAX · Traditional | 10/09/2014SE |
| K140162 | Ap Expandable Xlif SystemMAX · Traditional | 07/02/2014SE |
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Questions and answers
When was Simplify Disc cleared by the FDA?
Simplify Disc (K211757) received a 510(k) decision of Substantially Equivalent on August 20, 2021, 74 days after the submission was received.
What is the product code of K211757?
The FDA product code is QLQ – Manual Instruments Designed For Use With Total Disc Replacement Devices, a Class II (moderate risk) device regulated under 21 CFR 888.4515.