The following data is part of a premarket notification filed by Eisertech, Llc with the FDA for Plif Cage.
Device ID | K113478 |
510k Number | K113478 |
Device Name: | PLIF CAGE |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | EISERTECH, LLC 2555 FRONT STREET San Diego, CA 92103 |
Contact | Lukas Eisermann |
Correspondent | Lukas Eisermann EISERTECH, LLC 2555 FRONT STREET San Diego, CA 92103 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2011-11-23 |
Decision Date | 2012-03-05 |
Summary: | summary |