The following data is part of a premarket notification filed by Gold Standard Orthopaedics, Llc with the FDA for Gso Pct Spinal System.
| Device ID | K091359 |
| 510k Number | K091359 |
| Device Name: | GSO PCT SPINAL SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | GOLD STANDARD ORTHOPAEDICS, LLC 1226 ROWAN ST. Louisville, KY 40203 |
| Contact | David Baughman |
| Correspondent | David Baughman GOLD STANDARD ORTHOPAEDICS, LLC 1226 ROWAN ST. Louisville, KY 40203 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-08 |
| Decision Date | 2009-09-02 |
| Summary: | summary |