The following data is part of a premarket notification filed by Aurora Spine with the FDA for Interbody Cage System.
Device ID | K133967 |
510k Number | K133967 |
Device Name: | INTERBODY CAGE SYSTEM |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | AURORA SPINE 1331 H STREET NW, 12TH FLOOR Washington, DC 20005 |
Contact | Justin Eggleton |
Correspondent | Justin Eggleton AURORA SPINE 1331 H STREET NW, 12TH FLOOR Washington, DC 20005 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-12-24 |
Decision Date | 2014-01-31 |
Summary: | summary |