The following data is part of a premarket notification filed by Centinel Spine Llc with the FDA for Prodisc C Sk, Prodisc C Nova, And Prodisc C Vivo Instruments.
| Device ID | K221848 |
| 510k Number | K221848 |
| Device Name: | Prodisc C SK, Prodisc C Nova, And Prodisc C Vivo Instruments |
| Classification | Manual Instruments Designed For Use With Total Disc Replacement Devices |
| Applicant | Centinel Spine LLC 900 Airport Road, Suite 3B West Chester, PA 19380 |
| Contact | Jessica Staub |
| Correspondent | Justin Eggleton MCRA LLC 803 7th Street NW Washington, DC 20001 |
| Product Code | QLQ |
| CFR Regulation Number | 888.4515 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-06-24 |
| Decision Date | 2022-08-19 |