The following data is part of a premarket notification filed by Imedicom Co., Ltd. with the FDA for Spinaut-v, Spinaut-s, Spinaut-i.
| Device ID | K151268 |
| 510k Number | K151268 |
| Device Name: | SPINAUT-V, SPINAUT-S, SPINAUT-I |
| Classification | Arthroscope |
| Applicant | IMEDICOM CO., LTD. #612, 172, LS-ro Gunpo-si, KR 435-824 |
| Contact | Bonggu Ha |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 2651 E Chapman Ave Ste 110 Fullerton, CA 92831 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-13 |
| Decision Date | 2016-03-16 |
| Summary: | summary |