510(k) K231769
K231769 is an FDA 510(k) premarket notification submitted by Aesculap Implants Systems, LLC for the device "activL® Next Generation Instrumentation". The FDA issued a decision of Substantially Equivalent on Jul 13, 2023. 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. Aesculap Implants Systems, LLC has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 13, 2023
- Date Received
- Jun 16, 2023
- 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.