The following data is part of a premarket notification filed by Bk Meditech Co., Ltd. with the FDA for Pin Screw.
| Device ID | K061599 |
| 510k Number | K061599 |
| Device Name: | PIN SCREW |
| Classification | Pin, Fixation, Threaded |
| Applicant | BK MEDITECH CO., LTD. 215-5 YODANG-LI, YANGGAM-MYUN Hwasung-si, Kyunggi-do, KR |
| Contact | Byungjun Park |
| Correspondent | Byungjun Park BK MEDITECH CO., LTD. 215-5 YODANG-LI, YANGGAM-MYUN Hwasung-si, Kyunggi-do, KR |
| Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-08 |
| Decision Date | 2006-07-26 |
| Summary: | summary |