The following data is part of a premarket notification filed by Ulrich Gmbh & Co. Kg with the FDA for Tezo Titanium Cage Family.
| Device ID | K122957 |
| 510k Number | K122957 |
| Device Name: | TEZO TITANIUM CAGE FAMILY |
| 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 | 2012-09-25 |
| Decision Date | 2013-06-21 |
| Summary: | summary |