The following data is part of a premarket notification filed by Gold Standard Orthopedics Llc with the FDA for Gso Acp1 Anterior Cervical Plate System.
| Device ID | K110990 |
| 510k Number | K110990 |
| Device Name: | GSO ACP1 ANTERIOR CERVICAL PLATE SYSTEM |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | GOLD STANDARD ORTHOPEDICS LLC 3415 N. OLD FARM RD. E. Warsaw, IN 46582 |
| Contact | James Ritter |
| Correspondent | James Ritter GOLD STANDARD ORTHOPEDICS LLC 3415 N. OLD FARM RD. E. Warsaw, IN 46582 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-04-08 |
| Decision Date | 2011-07-25 |
| Summary: | summary |