The following data is part of a premarket notification filed by K2m, Llc. with the FDA for Santorini Corpectomy Cage System, Capri Corpectomy Cage System.
| Device ID | K180665 |
| 510k Number | K180665 |
| Device Name: | SANTORINI Corpectomy Cage System, CAPRI Corpectomy Cage System |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | K2M, LLC. 600 Hope Parkway SE Leesburg, VA 20175 |
| Contact | Nancy Giezen |
| Correspondent | Nancy Giezen K2M, LLC. 600 Hope Parkway SE Leesburg, VA 20175 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-14 |
| Decision Date | 2018-11-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857243200 | K180665 | 000 |
| 10888857023314 | K180665 | 000 |
| 10888857023475 | K180665 | 000 |
| 10888857023567 | K180665 | 000 |
| 10888857023673 | K180665 | 000 |
| 10888857023680 | K180665 | 000 |
| 10888857023697 | K180665 | 000 |
| 10888857023703 | K180665 | 000 |
| 10888857023710 | K180665 | 000 |
| 10888857023727 | K180665 | 000 |
| 10888857243071 | K180665 | 000 |
| 10888857243088 | K180665 | 000 |
| 10888857243163 | K180665 | 000 |
| 10888857530102 | K180665 | 000 |