The following data is part of a premarket notification filed by K2m with the FDA for Capri Corpectomy Cage System.
Device ID | K171704 |
510k Number | K171704 |
Device Name: | CAPRI Corpectomy Cage System |
Classification | Spinal Vertebral Body Replacement Device |
Applicant | K2M 600 Hope Parkway SE Leesburg, VA 20175 |
Contact | Nancy Giezen |
Correspondent | Nancy Giezen K2M 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 | 2017-06-08 |
Decision Date | 2017-08-31 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10888857371491 | K171704 | 000 |
10888857370708 | K171704 | 000 |
10888857370692 | K171704 | 000 |
10888857370685 | K171704 | 000 |
10888857370678 | K171704 | 000 |
10888857370630 | K171704 | 000 |
10888857370623 | K171704 | 000 |
10888857370616 | K171704 | 000 |
10888857370609 | K171704 | 000 |
10888857370593 | K171704 | 000 |
10888857370586 | K171704 | 000 |
10888857370562 | K171704 | 000 |
10888857370555 | K171704 | 000 |
10888857361935 | K171704 | 000 |
10888857361928 | K171704 | 000 |
10888857361911 | K171704 | 000 |
10888857361904 | K171704 | 000 |
10888857361874 | K171704 | 000 |
10888857370715 | K171704 | 000 |
10888857370722 | K171704 | 000 |
10888857371484 | K171704 | 000 |
10888857371118 | K171704 | 000 |
10888857371101 | K171704 | 000 |
10888857371088 | K171704 | 000 |
10888857371071 | K171704 | 000 |
10888857371033 | K171704 | 000 |
10888857371026 | K171704 | 000 |
10888857371019 | K171704 | 000 |
10888857371002 | K171704 | 000 |
10888857370999 | K171704 | 000 |
10888857370982 | K171704 | 000 |
10888857370951 | K171704 | 000 |
10888857370944 | K171704 | 000 |
10888857370791 | K171704 | 000 |
10888857370784 | K171704 | 000 |
10888857370777 | K171704 | 000 |
10888857370760 | K171704 | 000 |
10888857361867 | K171704 | 000 |