510(k) clearance
prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments
- 510(k) number
- K263159
- Applicant
- Centinel Spine, LLC
- Decision date
- Oct 7, 2026
- Date received
- Sep 9, 2026
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Product code
- QLQ
- Device type
- Manual Instruments Designed For Use With Total Disc Replacement Devices
- Device class
- Class II
- Regulation
- 21 CFR 888.4515
- Advisory committee
- Orthopedic
- Statement or summary
- Summary
- Third party
- N
- Location
- West Chester, PA, US