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 |