The following data is part of a premarket notification filed by Ulrich Medical Usa with the FDA for Ucerv Flux-c 3d Porous Titanium Cervical Interbody.
Device ID | K220696 |
510k Number | K220696 |
Device Name: | UCerv Flux-C 3D Porous Titanium Cervical Interbody |
Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
Applicant | Ulrich Medical USA 18221 Edison Avenue Chesterfield, MO 63005 |
Contact | Hans Stover |
Correspondent | Hans Stover Ulrich Medical USA 18221 Edison Avenue Chesterfield, MO 63005 |
Product Code | ODP |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2022-03-09 |
Decision Date | 2022-08-19 |