The following data is part of a premarket notification filed by Ulrich Gmbh & Co. Kg with the FDA for Pezo Interbody Cages System.
Device ID | K103814 |
510k Number | K103814 |
Device Name: | PEZO INTERBODY CAGES SYSTEM |
Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
Applicant | ULRICH GMBH & CO. KG 612 TRADE CENTER BLVD Chesterfield, MO 63005 |
Contact | Hans Stover |
Correspondent | Hans Stover ULRICH GMBH & CO. KG 612 TRADE CENTER BLVD Chesterfield, MO 63005 |
Product Code | MAX |
CFR Regulation Number | 888.3080 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2010-12-29 |
Decision Date | 2011-03-17 |
Summary: | summary |