510(k) K263159
K263159 is an FDA 510(k) premarket notification submitted by Centinel Spine, LLC for the device "prodisc® C; prodisc® C SK; prodisc® C Nova; prodisc® C Vivo Instruments". The FDA issued a decision of Substantially Equivalent on Oct 7, 2026. The device falls under product code QLQ (Manual Instruments Designed For Use With Total Disc Replacement Devices), a Class II device regulated under 21 CFR 888.4515. Centinel Spine, LLC has 14 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 7, 2026
- Date Received
- Sep 9, 2026
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Manual Instruments Designed For Use With Total Disc Replacement Devices
- Device Class
- Class II
- Regulation Number
- 888.4515
- Review Panel
- OR
- Submission Type
- 510(k)
The devices are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of total disc replacement devices.