The following data is part of a premarket notification filed by Gold Standard Orthopedics Llc with the FDA for Gso Gs1 Spacer.
| Device ID | K071274 |
| 510k Number | K071274 |
| Device Name: | GSO GS1 SPACER |
| Classification | Spinal Vertebral Body Replacement Device |
| Applicant | GOLD STANDARD ORTHOPEDICS LLC 1226 ROWAN ST. Louisville, KY 40203 |
| Contact | David Baughman |
| Correspondent | David Baughman GOLD STANDARD ORTHOPEDICS LLC 1226 ROWAN ST. Louisville, KY 40203 |
| Product Code | MQP |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-05-07 |
| Decision Date | 2007-08-24 |
| Summary: | summary |