The following data is part of a premarket notification filed by Surgident with the FDA for Gbr System.
| Device ID | K170697 |
| 510k Number | K170697 |
| Device Name: | GBR System |
| Classification | Plate, Bone |
| Applicant | SURGIDENT #209~210, Woolim Lion’s Valley, 27 Dunchon-daero 457 Beon-gil, Jungwon-gu Seongnam-si, KR 13219 |
| Contact | Duck-su Hur |
| Correspondent | Peter Chung Plus Global 300 Atwood Pittsburgh, PA 15213 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-03-07 |
| Decision Date | 2018-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08800041000258 | K170697 | 000 |
| 08800041000111 | K170697 | 000 |
| 08800041000104 | K170697 | 000 |
| 08800041000098 | K170697 | 000 |
| 08800041000081 | K170697 | 000 |
| 08800041000074 | K170697 | 000 |
| 08800041000067 | K170697 | 000 |
| 08800041000050 | K170697 | 000 |
| 08800041000043 | K170697 | 000 |
| 08800041000036 | K170697 | 000 |
| 08800041000029 | K170697 | 000 |
| 08800041000012 | K170697 | 000 |
| 08800041000128 | K170697 | 000 |
| 08800041000135 | K170697 | 000 |
| 08800041000241 | K170697 | 000 |
| 08800041000234 | K170697 | 000 |
| 08800041000227 | K170697 | 000 |
| 08800041000210 | K170697 | 000 |
| 08800041000203 | K170697 | 000 |
| 08800041000197 | K170697 | 000 |
| 08800041000180 | K170697 | 000 |
| 08800041000173 | K170697 | 000 |
| 08800041000166 | K170697 | 000 |
| 08800041000159 | K170697 | 000 |
| 08800041000142 | K170697 | 000 |
| 08800041000005 | K170697 | 000 |