The following data is part of a premarket notification filed by G Surgical Co., Ltd. with the FDA for Gps, G Surgical Pedicle System.
| Device ID | K081041 |
| 510k Number | K081041 |
| Device Name: | GPS, G SURGICAL PEDICLE SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | G SURGICAL CO., LTD. 152 SOI RAMKHAMHAENG 138 SAPANSUNG Bangkok, TH 10240 |
| Contact | Donald Grafton |
| Correspondent | Donald Grafton G SURGICAL CO., LTD. 152 SOI RAMKHAMHAENG 138 SAPANSUNG Bangkok, TH 10240 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-11 |
| Decision Date | 2008-06-27 |
| Summary: | summary |