The following data is part of a premarket notification filed by G Surgical Co., Ltd. with the FDA for Gps Tm, G Surgical Anterior Cervical Plate System +.
| Device ID | K103070 |
| 510k Number | K103070 |
| Device Name: | GPS TM, G SURGICAL ANTERIOR CERVICAL PLATE SYSTEM + |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| 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 | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-10-18 |
| Decision Date | 2011-01-12 |
| Summary: | summary |