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.
Device ID | K220861 |
510k Number | K220861 |
Device Name: | M6-C Artificial Cervical Disc Instruments AS |
Classification | Manual Instruments Designed For Use With Total Disc Replacement Devices |
Applicant | Spinal Kinetics LLC 501 Mercury Drive Sunnyvale, CA 94085 |
Contact | Joyce Zhong |
Correspondent | Joyce Zhong Spinal Kinetics LLC 501 Mercury Drive Sunnyvale, CA 94085 |
Product Code | QLQ |
CFR Regulation Number | 888.4515 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-03-24 |
Decision Date | 2022-06-02 |