K241117 is an FDA 510(k) clearance for the M6-C™ Single Use, Disposable 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 Spinal Kinetics / Orthofix / Seaspine (Sunnyvale, US). The FDA issued a Cleared decision on June 21, 2024, 59 days after receiving the submission on April 23, 2024.
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 | K241117 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 2024 |
| Decision Date | June 21, 2024 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| 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. |