The following data is part of a premarket notification filed by K2m, Inc. with the FDA for Capri Corpectomy Cage System.
| Device ID | K211320 |
| 510k Number | K211320 |
| Device Name: | CAPRI Corpectomy Cage System |
| Classification | Spinal Vertebral Body Replacement Device - Cervical |
| Applicant | K2M, Inc. 600 Hope Parkway SE Leesburg, VA 20175 |
| Contact | Renee Norby |
| Correspondent | Renee Norby K2M, Inc. 600 Hope Parkway SE Leesburg, VA 20175 |
| Product Code | PLR |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-30 |
| Decision Date | 2022-02-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888857523098 | K211320 | 000 |
| 10888857522961 | K211320 | 000 |
| 10888857522978 | K211320 | 000 |
| 10888857522985 | K211320 | 000 |
| 10888857522992 | K211320 | 000 |
| 10888857523005 | K211320 | 000 |
| 10888857523012 | K211320 | 000 |
| 10888857523029 | K211320 | 000 |
| 10888857523036 | K211320 | 000 |
| 10888857523043 | K211320 | 000 |
| 10888857523050 | K211320 | 000 |
| 10888857523067 | K211320 | 000 |
| 10888857523074 | K211320 | 000 |
| 10888857523081 | K211320 | 000 |
| 10888857522954 | K211320 | 000 |