The following data is part of a premarket notification filed by Eisertech, Llc with the FDA for Cervical Cage.
Device ID | K122444 |
510k Number | K122444 |
Device Name: | CERVICAL CAGE |
Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
Applicant | EISERTECH, LLC 1133 COLUMBIA STREET SUITE 107 San Diego, CA 92101 |
Contact | Lukas Eisermann |
Correspondent | Lukas Eisermann EISERTECH, LLC 1133 COLUMBIA STREET SUITE 107 San Diego, CA 92101 |
Product Code | ODP |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-08-10 |
Decision Date | 2012-08-30 |
Summary: | summary |