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510(k) K231769

activL® Next Generation Instrumentation by Aesculap Implants Systems, LLC — Product Code QLQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 13, 2023
Date Received
June 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

The devices are intended to manipulate tissue or implant materials for the positioning, alignment, defect creation, placement, or removal of total disc replacement devices.

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