The following data is part of a premarket notification filed by R Tree Innovations with the FDA for Epicage Interbody Fusion Device.
Device ID | K092901 |
510k Number | K092901 |
Device Name: | EPICAGE INTERBODY FUSION DEVICE |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | R TREE INNOVATIONS 13540 GUILD AVENUE Apple Valley, MN 55124 |
Contact | Richard Jansen |
Correspondent | Richard Jansen R TREE INNOVATIONS 13540 GUILD AVENUE Apple Valley, MN 55124 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-09-21 |
Decision Date | 2010-04-28 |
Summary: | summary |