The following data is part of a premarket notification filed by Amendia, Inc. with the FDA for Rectangular Corpectomy Cage.
| Device ID | K152460 |
| 510k Number | K152460 |
| Device Name: | Rectangular Corpectomy Cage |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | Amendia, Inc. 1755 West Oak Parkway Marietta, GA 30062 |
| Contact | Bruce Hooper |
| Correspondent | Chelsea Proffitt AMENDIA, INC. 1755 WEST OAK PARKWAY Marietta, GA 30062 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-08-28 |
| Decision Date | 2015-12-22 |
| Summary: | summary |