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 |