The following data is part of a premarket notification filed by Ulrich Gmbh & Co. Kg with the FDA for Golden Gate Anterior Plate System.
| Device ID | K101353 |
| 510k Number | K101353 |
| Device Name: | GOLDEN GATE ANTERIOR PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | ULRICH GMBH & CO. KG 754 SPIRIT 40 PARK DRIVE Chesterfield, MO 63005 |
| Contact | Hans Stover |
| Correspondent | Hans Stover ULRICH GMBH & CO. KG 754 SPIRIT 40 PARK DRIVE Chesterfield, MO 63005 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-14 |
| Decision Date | 2011-02-04 |
| Summary: | summary |