510(k) K250554
K250554 is an FDA 510(k) premarket notification submitted by Centinel Spine, LLC for the device "prodisc® L Instruments". The FDA issued a decision of Substantially Equivalent on April 25, 2025. 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 at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 2025
- Date Received
- February 25, 2025
- Clearance Type
- Traditional
- 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
The devices are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of total disc replacement devices.