The following data is part of a premarket notification filed by K2m with the FDA for Capri Corpectomy Cage System.
Device ID | K170055 |
510k Number | K170055 |
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 | 2017-01-06 |
Decision Date | 2017-04-13 |
Summary: | summary |