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510(k) K220861

Device
M6-C Artificial Cervical Disc Instruments AS
Applicant
Spinal Kinetics LLC
510(k) number
K220861
Product code
QLQ  
Decision
Substantially Equivalent (SESE)
Decision date
2022-06-02
Date received
2022-03-24
Regulation
888.4515
Classification name
Manual Instruments Designed For Use With Total Disc Replacement Devices
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Joyce Zhong
Address
501 Mercury Dr. Sunnyvale CA US 94085 94085

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QLQ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253392Synergy Disc InstrumentsSynergy Spine Solutions, Inc.2026-03-27
K250554prodisc® L InstrumentsCentinel Spine, LLC2025-04-25
K242869prodisc® L InstrumentsCentinel Spine, LLC2024-12-17
K241117M6-C™ Single Use, Disposable InstrumentationSpinal Kinetics / Orthofix / Seaspine2024-06-21
K231769activL® Next Generation InstrumentationAesculap Implants Systems, LLC2023-07-13
K221848prodisc C SK, prodisc C Nova, and prodisc C Vivo InstrumentsCentinel Spine, LLC2022-08-19
K211757Simplify DiscNuvasive, Inc.2021-08-20

Legacy Summary#

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FDA Review#

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