K231769 is an FDA 510(k) clearance for the activL® Next Generation Instrumentation. This device is classified as a Manual Instruments Designed For Use With Total Disc Replacement Devices (Class II - Special Controls, product code QLQ).
Submitted by Aesculap Implants Systems, LLC (Center Valley, US). The FDA issued a Cleared decision on July 13, 2023, 27 days after receiving the submission on June 16, 2023.
This device falls under the Orthopedic FDA review panel. Regulated under 21 CFR 888.4515. The Devices Are Intended To Manipulate Tissue Or Implant Materials For The Positioning, Alignment, Defect Creation, Placement, Or Removal Of Total Disc Replacement Devices..
| 510(k) Number | K231769 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 16, 2023 |
| Decision Date | July 13, 2023 |
| Days to Decision | 27 days |
| Submission Type | Special |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
| Product Code | QLQ - Manual Instruments Designed For Use With Total Disc Replacement Devices |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 888.4515 |
| Definition | The Devices Are Intended To Manipulate Tissue Or Implant Materials For The Positioning, Alignment, Defect Creation, Placement, Or Removal Of Total Disc Replacement Devices. |