M6-C Artificial Cervical Disc Instruments AS

Manual Instruments Designed For Use With Total Disc Replacement Devices

Spinal Kinetics LLC

The following data is part of a premarket notification filed by Spinal Kinetics Llc with the FDA for M6-c Artificial Cervical Disc Instruments As.

Pre-market Notification Details

Device IDK220861
510k NumberK220861
Device Name:M6-C Artificial Cervical Disc Instruments AS
ClassificationManual Instruments Designed For Use With Total Disc Replacement Devices
Applicant Spinal Kinetics LLC 501 Mercury Drive Sunnyvale,  CA  94085
ContactJoyce Zhong
CorrespondentJoyce Zhong
Spinal Kinetics LLC 501 Mercury Drive Sunnyvale,  CA  94085
Product CodeQLQ  
CFR Regulation Number888.4515 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2022-03-24
Decision Date2022-06-02

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