The following data is part of a premarket notification filed by Amendia, Inc. with the FDA for Amendia Interbody Fusion Devices.
Device ID | K160924 |
510k Number | K160924 |
Device Name: | Amendia Interbody Fusion Devices |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
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 | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-04-04 |
Decision Date | 2016-11-08 |
Summary: | summary |